Safety

Enforcement Report for March 21, 2012

March 21, 2012
12-12
 
RECALLS AND FIELD CORRECTIONS:FOODS - CLASS I

PRODUCT
1)Edelweiss Creamery, A premium Fondue Blend and Swiss Style, Emmentaler Swiss & Gruyere Cheese, Net Wt 16 oz (448 g), Manufactured 12/5/2011, UPC 7 58590 11691 4. Recall # F-0885-2012;
 
2) 8/2.5 lbs Shredded Mozzarella Cheese (suisee haus), Net Wt 20 lbs Pack date 04 Jan 2012, Manufactured 12/8/2011. Recall # F-0886-2012;
 
3) 5 lbs Parmesan, Miller's Cheese, Manufactured 12/8/2011, UPC 0 7881236350 7. Recall # F-0887-2012;
 
4) Nuestro Queso, Cotija En Polvo. Net Wt 7 oz (198 g), UPC 8 14633 01302 9. Net Wt 16 oz. (453.6g) UPC 8 14633 01300 5. HEB Queso Cotija, Net Wt 8 oz (226g) UPC 0 4122024846 9. a) Nuestro Queso Manufactured 10/21/2011; Manufactured 10/05/2011 7 oz; b)HEB Manufactured 11/28/2011 8 oz; Manufactured 11/10/2011 8 oz. Recall # F-0888-2012;
 
5) Brennan's Cellars, Part Skim Mozzarella Cheese, Net Wt 16 oz (448g), UPC 0 3344135324 4. Manufactured on 11/08/2011. Recall # F-0889-2012
CODE
1)Code Date 339A11;
 
2) Code Date 342A11;
 
3) Code Date 8-Dec-2011;
 
4) a) Code Date 18FEB12; Code Date 02FEB12 7; b) Code date: 27 mar 2012; Code date: 9 mar 2012;
 
5) Code date: 27 mar 2012
RECALLING FIRM/MANUFACTURER
Alpine Slicing and Cheese Conversion Co., Monroe,WI, by e-mail, and press release on December 23, 2011 and letter dated December 29, 2011. FDA initiated recall is ongoing.
REASON
The shredded/grated cheeses were found to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
312,806.65 lbs for all cheese types
DISTRIBUTION
NY, IL, WI

PRODUCT
1) Mustard Potato Salad sold under the following brand names: 1) Deli Fresh Gourmet Mustard Potato Salad, Net Wt 16 oz - UPC 718129010014, Net Wt 32 oz - UPC 718129010021 Net Wt 48 oz - UPC 718129010038 2) Hill Country Fare Deli Style Mustard Potato Salad, Net Wt 80 oz - UPC 041220031726 Net Wt 16 oz - UPC 041220031641 Net Wt 48 oz - UPC 041220031658 Net Wt 6 oz - UPC 041220867851 3) Allison's Gourmet Kitchens Gourmet Mustard Potato Salad 4) Chef Prepared Mustard Potato Salad, Net Wt 80 oz, UPC 718129038964. Recall # F-0893-2012;
 
2) Potato Salad with Egg sold under the following brand names: 1) Deli Fresh Gourmet Potato Salad with Egg, Net Wt 16 oz - UPC 718129010212 Net Wt 32 oz - UPC 718129010229 Net Wt 48 oz - UPC 718129010236; 2) Allison's Gourmet Kitchens Potato Salad with Egg, Net Wt 80 oz - UPC 718129017549. Recall # F-0894-2012;
 
3) Hill Country Fare Homestyle Potato Salad Net Wt 16 oz - UPC 041220031665 Net Wt 48 oz - UPC 041220031672 Net Wt 80 oz - UPC 041220185740. Recall # F-0895-2012;
 
4) Deviled Egg Potato Salad sold under the following brand names: 1) Allison's Gourmet Kitchens Deviled Egg Potato Salad deli fresh ; Net Wt 16 oz - UPC 718129012018 Net Wt 32 oz - UPC 718129012025, 80 oz; 2) Food Lion Gourmet Deviled Egg Potato Salad, Net Wt 16 oz - UPC 035826075871. Recall # F-0896-2012;
 
5) Diced Redskin Potato sold under the following brand names: 1) Deli Fresh Diced Redskin Potato Salad Net Wt 16 oz UPC 718129012209; 2) Allison's Gourmet Kitchens, Diced Redskin Potato Salad; 3) Hannaford Diced Red Skin Potato Salad Net Wt 16 oz, UPC 041268178834. Recall # F-0897-2012;
 
6) Redskin Potato Salad sold under the following brand names: 1) Allison's Gourmet Kitchens, Redskin Potato Net Wt 5 LBS UPC 718129017570; 2) Produce House Made Fresh-Never Frozen! Redskin Potato Salad Net Wt 80 oz - 718129019598; 3) Food Lion Gourmet Redskin Potato Salad Net Wt 16 oz, UPC 035826069337. Recall # F-0898-2012;
 
7) Baker's Kitchen Old Fashioned Potato Salad Net Wt 5 lb UPC 718129017839. Recall # F-0899-2012;
 
8) Southern Potato Salad sold under the following brand names: 1) Food Lion Gourmet Southern Potato Salad, Net Wt 16 oz - UPC 035826070647, Net Wt 48 oz - UPC 035826070654; 2) Hannaford Southern Potato Salad Net Wt 48 oz UPC 041268180844; 3) Brookshire's Classic Southern Potato Salad, Net Wt 16 oz - UPC 092825145257 Net Wt 48 oz - UPC 092825145219. Recall # F-0900-2012;
 
9) Food Lion Gourmet American Potato Salad Net Wt 16 oz - UPC 035826070661 Net Wt 48 oz - UPC 035826070678. Recall # F-0901-2012;
 
10) Hannaford Potato Salad Net Wt 48 oz - UPC 041268180837 Net Wt 16 oz - UPC 041268178803. Recall # F-0902-2012;
 
11) Macaroni Salad sold under the following brand names: 1) Allison's Gourmet Kitchens Classic Macaroni Salad; 2) Baker's Kitchen Macaroni Salad Net Wt 5 lb. UPC 718129038025, 30 LB - UPC 718129037554 1 60 oz - UPC 718129037547. Recall # F-0903-2012;
 
12) Chef Prepared Aunt Pearls Potato Salad Net Wt 80 oz UPC 718129038988. Recall # F-0904-2012;
 
13) Hill Country Fare Deli Style Homestyle Pea Salad Net Wt 15 oz, UPC 041220813162. Recall # F-0905-2012;
 
14) Egg Salad sold under the following brand names: 1) Produce House Made Fresh-Never Frozen Egg Salad Net Wt 48 oz, UPC 718129049557; 2) Allison's Egg Salad Net Wt 48 oz UPC 718129080802; 3) Hill Country Fare Deli Style Homestyle Egg Salad Net Wt 12 oz UPC 041220202577. Recall # F-0906-2012;
 
15) Baker's Kitchen Country Potato Salad Net Wt 5 lbs. UPC 718129017846. Recall # F-0907-2012;
 
16) Allison's Gourmet Kitchens New Orleans Style Potato Salad, Net Wt 80 oz, UPC 718129011400. Recall # F-0908-2012
CODE
1) Net Wt 16 oz - Use By 03/12/2012 & 03/14/2012 Net Wt 32 oz - Use By 3/14/2012 Net Wt 48 oz - Use By 03/12/2012, 03/14/2012 & 3/19/2012 2) Net Wt 80 oz - Use By 3/12/2012, 3/14/2012, & 3/19/2012 Net Wt 16 oz - Use By 3/12/2012, 3/14/2012, 3/15/2012, 3/19/2012 & 3/20/2012 Net Wt 48 oz - Use By 3/14/2012, 3/15/2012, & 3/19/2012 Net Wt 6 oz - Use By 03/12/2012, 03/13/2012, 3/19/2012 3) Net Wt 160 oz - Use By 3/14/2012 Net Wt 80 oz - Use By 3/12/2012 & 3/19/2012 4) Use By 1/28/2012, 1/29/2012, 1/31/2012, 2/4/2012, & 2/8/2012;
 
2) Net Wt 16 oz - Use By 3/13/2012 & 3/15/2012 Net Wt 32 oz - Use By 3/15/2012 Net Wt 48 oz - Use By 3/13/2012 & 3/15/2012; 2) UPC 718129017549 - Use By 3/12/2012 & 3/15/2012 UPC 718129019321 - 3/13/2012 & 3/19/2012
 
3) Net Wt 16 oz - Use By 3/13/2012 & 3/15/2012 Net Wt 48 oz - Use By 3/13/2012, 3/19/2012 Net Wt 80 oz - Use By 3/13/2012, 3/15/2012, 3/19/2012;
 
4) 1) Net Wt 16 oz - Use By 3/15/2012, Net Wt 32 oz - Use By 3/15/2012; Net Wt. 80 oz - Use By 3/13/2012 & 3/15/2012 Net Wt 160 oz - Use By 3/15/2012; 2) Food Lion Gourmet Deviled Egg Potato Salad, Net Wt 16 oz - Use By 3/12/2012;
 
5) 1) Use By 3/14/2012; 2) Net Wt 60 oz - Use By 3/12/2012 Net Wt 80 oz - Use By 3/19/2012; 3) Use By 3/12/2012 & 3/14/2012;
 
6) 1) Use By 3/13/2012 & 3/21/2012; 2) Use By 3/13/2012; 3) Use By 3/12/2012 & 3/14/2012;
 
7) Use By 3/14/2012;
 
8) 1) Net Wt 16 oz - Use By 3/12/2012 & 3/15/2012 Net Wt 48 oz - Use By 3/12/2012 & 3/15/2012; 2) Use By 3/15/2012; 3) Net Wt 16 oz - Use By 3/12/2012 & 3/19/2012 Net Wt 48 oz - Use By 3/12/2012 & 3/19/2012;
 
9) Net Wt 16 oz - Use By 3/13/2012 & 3/15/2012 Net Wt 48 oz - 3/13/2012 & 3/15/2012;
 
10) Net Wt 48 oz - Use By 3/13/2012 Net Wt 16 oz - Use By 3/13/2012 & 3/15/2012;
 
11) 1) 30 lb - Use by 3/12/2012, 160 oz, Use by 3/18/2012; 2) Use by 3/12/2012 & 3/15/2012;
 
12) Use By 1/28/2012, 1/29/2012, 1/31/2012, 2/4/2012, & 2/8/2012;
 
13) Use By 2/24/2012, 3/2/2012, & 3/4/2012;
 
14) 1) Use By 3/2/2012 & 3/3/2012; 2) Use By 3/2/2012; 3) Use By 2/29/2012, 3/2/2012, & 3/5/2012;
 
15) Use By 3/17/2012;
 
16) Use By 3/10/2012
RECALLING FIRM/MANUFACTURER
Vaughan Foods Inc, (Allison's Gourmet Kitchen), Moore, OK, by letter on January 27, 2012 and by press release and letters on February 2, 2012. Firm initiated recall is ongoing.
REASON
The products have the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
15,464 cases
DISTRIBUTION
Nationwide

PRODUCT
1) Apple Streusel Pie --- Sizes: 8" UPC 41735-25207; 5" UPC 41735-25253; 5" UPC 41735-25209. Sold in retail stores' bakery departments. Recall # F-0909-2012;
 
2) Cherry Streusel Pie --- Sizes: 8" UPC 41735-25229; 5" UPC 41735-25252. Sold in retail stores' bakery departments. Recall # F-0910-2012;
 
3) Blueberry Streusel Pie --- Sizes: 8" UPC 41735-25210; 5" UPC 41735-25220. Sold in retail stores' bakery departments. Recall # F-0911-2012;
 
4) 8" Peach Streusel Pie --- UPC 41735-25205. Sold in retail stores' bakery departments. Recall # F-0912-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Price Chopper, Schenectady, NY, by press release on February 27, 2012. Firm initiated recall is ongoing.
REASON
Recall due to the presence of undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, VT, CT, PA, MA, NH
 
RECALLS AND FIELD CORRECTIONS:FOODS - CLASS II

PRODUCT
1) Aunt Jemima Buttermilk Pancakes 12 count Keep Frozen Net Wt. 14.8 oz (420g), UPC 19600-05100; Serving Size 3 pancakes (105g). Recall # F-0743-2012;
 
2) Aunt Jemima Whole Grain Pancakes 12 count Keep Frozen Net Wt. 14.5 oz (411g), UPC 19600-06040; Serving Size 3 pancakes (103g). Recall # F-0744-2012;
 
3) Aunt Jemima Low Fat Pancakes 12 count Keep Frozen Net Wt. 14.5 oz (411g), UPC 19600-05100; Serving Size 3 pancakes (103g). Recall # F-0745-2012;
 
4) Aunt Jemima Confetti Pancakes 12 count Keep Frozen Net Wt. 14.8 oz (420g), UPC 19600-05955; Serving Size 3 pancakes (105g). Recall # F-0746-2012;
 
5) Aunt Jemima Oatmeal Pancakes 12 count Keep Frozen Net Wt. 14.8 oz (420g), UPC 19600-05490; Serving Size 3 pancakes (105g). Recall # F-0747-2012;
 
6) Aunt Jemima Homestyle Pancakes 12 count Keep Frozen Net Wt. 14.8 oz (420g), UPC 19600-05910; Serving Size 3 pancakes (105g). Recall # F-0748-2012
CODE
Use By Date between November 1, 2011 up to and including October 16, 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pinnacle Food Corp., Mountain Lakes, NJ, by press release and letter on January 27, 2012.
Manufacturer: Pinnacle Foods Group, Jackson, TN. Firm initiated recall is ongoing.
REASON
Frozen pancakes may contain undeclared soy protein.
VOLUME OF PRODUCT IN COMMERCE
764,634 cases US; 83,246 cases Canada
DISTRIBUTION
Nationwide and Canada

PRODUCT
1) Colored Cheddar: Brennan's Cellars Mild Colored Cheddar Cheese, Net Wt 16 oz (448 g), UPC 0 3344135322 0. Colored Cheddar 18-Feb-12.Shred Muenster: Haolam, Munster, Shredded natural Cheese, Net Wt 8 oz (226 g) UPC 0 2663826700 4. Haolam 4/5# N/A No label Haolam 4/5# N/A No Cheese 4/5# 0 7881236960 8 No label. UPC CODE 0 2663826700 0 2663826700 4 label Miller's Cheese, Muenster Cheese, Net Wt 8 oz (226g) UPC 0 7881236960 8. Miller's 0 7881236960 8 Haolam Haolam0 7881236960 8. Recall # F-0864-2012;
 
2) Edelweiss Creamery, A premium Fondue Blend and Swiss Style, Emmentaler Swiss & Gruyere Cheese, Net Wt 16 oz (448 g). UPC 7 58590 11691 4. Brennan's Foundue Cheese - No label available. Recall # F-0865-2012;
 
3) Grated Cotija: Acerrin, Grated Aged Cheese, Net Wt 7 oz. (198 g), UPC 8 1463301420 0. Cuervito Morado, Cotija Powder, Net Wt 16 oz. (453 g), UPC 6 30535 00022 2. El Viajero, Queso Cotija, Net Wt 4 lb (1.8 kg), UPC 0 72820 32049 1. Nuestro Queso, Cotija En Polvo. Net Wt 16 oz. (453.6g) UPC 8 14633 01300 5. Net Wt 5 lb (2.3 kg) UPC 8 14633 01301 2. HEB Queso Cotija, Net Wt 8 oz (226g) UPC 0 4122024846 9. 8 14633 01301 0 4122024846 9. F-0866-2012;
 
4) Mozzarella: Brennan's Cellars, Part Skim Mozzarella Cheese, Net Wt 16 oz (448g), UPC 0 3344135324 4. Recall # F-0867-2012;
 
5) Shred Colored Cheddar: Haolam, Cheddar Shredded Natural Cheese, Net Wt 8 oz (226G), UPC 0 2663826200 9. Haolam 4/5# (no label) Miller's Cheese, Shredded Cheddar Cheese, Net Wt 5 lb. (2.26 Kg), UPC 0 7881236620 1. Miller's Cheese, Cheddar Cheese, NET WT 8oz (226g), UPC 0 7881236950 9. Recall # F-0868-2012;
 
6) Shred Duranguense: Nuestro Queso, Duranguense Rallado, Net Wt 5 lb (80 oz), UPC 8 14633 01085 1. Plant #17-209. 18/7 oz, UPC 8 14633 01083 7 - No label 12/16 oz. (453g) UPC 8 14633 01082 0. Recall # F-0869-2012;
 
7) Shred Fancy (Mozz/Col Cheddar): Miller's Cheese, Mozzarella & Cheddar Cheese, Fancy Shredded, Net Wt 8oz (226g), UPC 0 7881236955 4. Recall # F-0870-2012;
 
8) Shred Fancy Mozz/Cheddar Blend: Haolam, Mozzarella & Cheddar, Fancy Shredded natural Cheese, Net wt 8 oz (226g), UPC 0 2663826500 0. Recall # F-0871-2012;
 
9) Shred Goat Cheddar: Nordic Creamery, Grumpy Goat Shreds, Goat Milk, Net wt 8 oz (227g), UPC 8 9319300233 9. Recall #F-0872-2012;
 
10) Shred Gourmet Blend: Haolam, Mozzarella & Cheddar, Gourmet Blend Shredded Natural Cheese, Net wt 2 lbs (907g), UPC 0 2663826505 5. Recall F-0873-2012;
 
11) Shred Monterey Jack Miller's Cheese 4/5# No label Maple Leaf Cheese Sales 8/2.5# No label. UPC CODE Miller's Cheese Maple Leaf Cheese Sales 314A11. Recall # F-0874-2012
 
12) Shred Mozzarella: Miller's Cheese, Mozzarella Cheese, Net Wt 8 oz (226 g), UPC 0 78812 00910 8. Miller's Cheese, 1 lb (453 g) UPC 0 78812 36605 8. Miller's Cheese, 2 lbs (907 g), UPC 0 78812 36615 7. Miller's Cheese, 5 lb (2.268kg), UPC 0 78812 36610 2. Rackow Family Sausage 8/2.5# no label Suisse Haus 8/2.5# no label Haolam, Mozzarella, Shredded Natural Cheese, Net wt 8 oz (226 g), UPC 026638 00264 3. Haolam, 16 oz (453 g), UPC 0 26638 26402 7 Haolam, 2 lbs (907 g) UPC 0 26638 26405 8. Haolam, 5 lb (2.268kg) UPC 0 26638 26410 2. UPC 0 7881200910 8. Recall # F-0875-2012;
 
13) Shred Muenster: Haolam, Munster, Shredded natural Cheese, Net Wt 8 oz (226g) UPC 0 2663826700 4. Haolam 4/5# N/A No label Haolam 4/5# N/A No label Miller's Cheese, Muenster Cheese, Net Wt 8 oz (226g) UPC 0 7881236960 8. Miller's Cheese 4/5# 0 7881236960 8 No label. UPC 0 2663826700 4 0 2663826700 4 0 7881236960 8 0 7881236960 8. Recall # F-0876-2012;
 
14) Shred Parmesan Miller's Cheese 4/5# 0 7881236350 7 No label. UPC 0 7881236350 7. Recall # F-0877-2012;
 
15) Shred Pizza Cheese: Haolam, Pizza Shredded Natural Cheese, Net Wt 8 oz (226 g), UPC 0 2663826300 6. Recall # F-0878;
 
16) Shred Pizza Cheese (Mozz/Muenster) Haolam 12/8 oz 0 2663826300 6 (see #15) Miller's Cheese, Shredded Pizza Cheese, Net Wt 8 oz (226 g), UPC 0 7881236945 5, UPC CODE 0 2663826300 6 0 7881236945 5. Recall # F- 0879-2012;
 
17) Shred Quesadilla: BMF, Queso Quesadilla, Menonita Syle Melting Cheese, Net Wt 5 lbs (2.27 kg). El Viajero, Queso Qesadilla, Net Wt 8 oz (227G), UPC 0 72820 14045 7, Best Mexican Foods UPC 0 7282014045 7. Recall # F-0880-2012;
 
18) Shred Reduced Fat Colored Cheddar Haolam, Reduced Fat Cheddar, Shredded natural Cheese, Net Wt 8 oz, UPC 0 2663827900 7, UPC 0 2663827900 7. Recall # F-0881-2012;
 
19) Shred Reduced Fat Muenster: Haolam, Reduced Fat Muenster, Shredded Natural Cheese, Net Wt 8 oz (226g), UPC 0 2663827700 3, UPC 0 2663827700 3. Recall # F-0882-2012;
 
20) Shred White Cheddar Haolam 4/5# Miller's Cheese 4/5# 0 7881236620 1 see #5 No labels. UPC Haolam 0 7881236620 1. Recall # F-0883-2012;
 
21) Goat Mozzarella, 8 oz, Pasture Pride No labels. Manufacturing date: 11-23-11. Recall # F-0884-2012;
CODE
1) 4 3-Jul-12 4-Sep-12 10-Jul-12 5-Oct-11 7-Dec-11 17-Nov-11;
 
2) Code 290A11;
 
3) 27-Mar-12 18-Feb-12 22-Mar-12 2-Feb-12 9-Mar-12 17-Feb-12 21-Feb-12 8-Feb-12 18-Feb-12 21-Feb-12 10-Mar-12 22-Mar-12 20-Mar-12;
 
4) 18-Feb-12 17-Feb-12 3-Mar-12 6-Mar-12 10-Mar-12 17-Mar-12;
 
5) 3-Jul-12 19-Feb-1228-Aug-12 19-Feb-12 10-Jul-12 12-Feb-12 16-Feb-12 19-Feb-1228-Aug-124-Oct-11 1-Mar-12 15-Mar-12 3-Oct-1130-Nov-11 9-Mar-12 15-Mar-12;
 
6) 5-Jan-12 9-Mar-12 5-Jan-12;
 
7) 10-Jul-12 24-Jul-12 7-Aug-12 19-Aug-12;
 
8) 3-Jul-12 24-Jul-12 31-Jul-12 14-Aug-12 4-Sep-12 31-Jul-12 9-Apr-12 16-Apr-12 21-Apr-12;
 
9) 10-Mar-12 7-Apr-12 24-Jul-12 31-Jul-12 7-Aug-12 14-Aug-12;
 
10) 5-Mar-12 31-Jul-12 19-Aug-12 30-Apr-12 31-Jul-12 14-Aug-12;
 
11) 4-Oct-11 24-Jul-12 31-Jul-12 7-Aug-12 24-Jul-12 31-Jul-12;
 
12) 3-Jul-12 3-Nov-11 16-Nov-11 28-Aug-12 7-Aug-12 21-Aug-12 5-Mar-12 10-Oct-11 3-Nov-11 22-Nov-11 30-Apr-12 26-Oct-11 9-Nov-11 22-Nov-117-Aug-12 16-Nov-11 10-Jul-12 24-Jul-12 7-Aug-12 14-Aug-12 21-Aug-1228-Aug-12 9-Apr-1210-Jul-12 4-Sep-12 17-Nov-11 26-Mar-12 14-Aug-12 30-Apr-12 3-Oct-11 31-Jul-12 21-Aug-12 30-Nov-11 17-Nov-11 1-Dec-11 10-Oct-11 25-Oct-11 26-Oct-11 4-Nov-11 17-Nov-11 4-Oct-11 2-Apr-12 9-Apr-12 21-Apr-12 4-Oct-11 10-Oct-11 25-Oct-11 3-Nov-11 8-Nov-11 16-Nov-11 22-Nov-11;
 
13) 3-Jul-12 4-Sep-12 10-Jul-12 5-Oct-11 7-Dec-11 17-Nov-11;
 
14) 4-Sep-12;
 
15) 28-Aug-12;
 
16) 10-Jul-12 3-Jul-12 4-Sep-12;
 
17) 16-Feb-12 4-Sep-12 30-Mar-12 7-May-1224-Feb-12 4-Sep-12 30-Mar-12 7-May-12;
 
18) 7-Aug-12 7-Dec-11;
 
19) 10-Jul-12 28-Aug-12;
 
20) 7-Dec-11 0 7881236620 1 9-Nov-11 4-Sep-12;
 
21) Code date: 327A11;
RECALLING FIRM/MANUFACTURER
Alpine Slicing and Cheese Conversion Co., Monroe,WI, by e-mail, and press release on December 23, 2011 and letter dated December 29, 2011. FDA initiated recall is ongoing.
REASON
The shredded/grated cheeses were found to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
312,806.65 lbs for all cheese types
DISTRIBUTION
NY, IL, WI

PRODUCT
Schnucks Beef Flavor Instant Bouillon, Net Wt 3.75 oz, UPC 041318030617. Recall # F-0891-2012
CODE
Best Before Nov 18, 2013
RECALLING FIRM/MANUFACTURER
Associated Brands, Inc., Medina,NY, by telephone on February 13, 2012 and February 14, 2012. Firm initiated recall is ongoing.
REASON
A small portion of the lot is mislabeled and may contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
3,372 units
DISTRIBUTION
MO

PRODUCT
Jelly Belly Peter Rabbit Deluxe Easter Mix., Net Wt. 2.7 oz (76 g), Package includes assorted jelly beans, bunny corn, chocolate malted eggs, mellocreme bunnies and foil wrapped chocolate eggs. Item number: 41715. Recall # F-0892-2012
CODE
Lot Codes: 111111 Best before Jan 11, 2013 111215 Best before Feb 15, 2013 111216 Best before Feb 15, 2013. 120120 Best before Mar 20, 2013
RECALLING FIRM/MANUFACTURER
Jelly Belly Candy Co., Fairfield,CA, by telephone on February 28, 2012, followed by a letter on February 29, 2012. Firm initiated recall is ongoing.
REASON
Firm received a complaint regarding a reaction to gluten, and discovered that the package has a "Gluten Free" banner, while the malted milk balls have wheat in them.
VOLUME OF PRODUCT IN COMMERCE
5,260 cases
DISTRIBUTION
Nationwide

PRODUCT
1) Subway Italian White Bread Dough Sticks, Item number: S003337V. Product is packed in bulk 26.25 lb boxes. Recall # F-0913-2012;
 
2) Subway 9-Grain (6.5oz) Wheat Bread Dough Sticks, Item number: S003614V, Contains 70 -6.5oz (184 g) Sticks, Product is packed in bulk 28.4 lbs boxes. Recall # F-0914-2012
CODE
1) Batch numbers: 2VN022A3, 2VN022A6, 2VN035A6, 2VN035B6, 2VN035C6, 2VN037A3, 2VN037A4, 2VN037A6, 2VN037B3, 2VN037B4, 2VN037B6, 2VN037C3, 2VN037C4, 2VN037C6 and 2VN038C6;
 
2) Batch numbers: 2VN022A2, 2VN035A2, 2VN035A3, 2VN035A4, 2VN035B2, 2VN035B3, 2VN035B4, 2VN035C2, 2VN035C3, 2VN035C4, 2VN037B2, 2VN038A2, 2VN038C2, and 2VN039C2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Otis Spunkmeyer Inc., Cayce, SC, by telephone and email on February 9, 2012.
Manufacturer: Otis Spunkmeyer LLC, Vinita,OK. Firm initiated recall is ongoing.
REASON
Products contain dough conditioner recalled by Caravan Ingredients due to foreign material (metal fragments) found in the product.
VOLUME OF PRODUCT IN COMMERCE
82,520 cases
DISTRIBUTION
CA, KS, KY, MO, NM, OH, OK, TN and UT

PRODUCT
"***Simplot traditions 100% REAL SEASONED POTATO FLAKES***NET WT 28 OZ (794g)***INGREDIENTS: IDAHO POTATOES, SUNFLOWER OIL, CORN SYRUP SOLIDS, SALT, CONTAINS LESS THAN 1% OF THE FOLLOWING: NATURAL FLAVORS, SODIUM CASEINATE***CONTAINS: SOY, SULFITES, Made on equipment that also processes ingredients containing Milk, Wheat.***" SKU: 7117902288. Recall # F-0915-2012
CODE
All day codes
RECALLING FIRM/MANUFACTURER
Simplot Food Group, Boise,ID, by telephone on January 26, 2012. Firm initiated recall is ongoing.
REASON
The product contains sodium caseinate. Milk was mistakenly added to the precautionary statement below the contains statement, rather than in the "Contains:" statement.
VOLUME OF PRODUCT IN COMMERCE
4,233 cases / 12 - 28 ounce pouches per case
DISTRIBUTION
AL, IL, LA, NE, NM, PA, TX, VA and WI

PRODUCT
Rhythm Superfoods Kool Ranch Kale Chips; Net Wt 2.0 oz (57g). Gusset Bag 8.5 h x 6.875 w x 3 d, 12 units per case. UPC: 8 29739 00052 1. Recall # F-0916-2012
CODE
Lot Codes (Sell by Date): 03/26/12, 03/27/12, 03/28/12, 04/03/12, 04/04/12, 04/10/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhythm Superfoods, Austin, TX, by letter on December 5, 2011.
Manufacturer: Bartush-Schnitzius Foods Co., Lewisville,TX. Firm initiated recall is ongoing.
REASON
The firm's recalling their reconditioned Kool Ranch Kale Chips because they the product was distributed prior to approval of the reconditioning plan, which did not comply with section 403W of the F, D & C Act for labeling a product that contains a major food allergen.
VOLUME OF PRODUCT IN COMMERCE
2,704 cases
DISTRIBUTION
CA, FL, IL, IN, NY, TX, and RI
 
RECALLS AND FIELD CORRECTIONS:FOODS - CLASS III

PRODUCT
Burrata Cheese, Mozzarella Buratta, approximately 300 g, Made in Italy --- Each unit is packed in plastic wrapping, 12 units per case.(To eat no later than: 04.30.2011). Recall # F-0917-2012
CODE
Lot 1216
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranieri Fine Food Corp., Brooklyn,NY, by letters, dated May 11, 2011.
Manufacturer: Cap Cooperative Allevatori Putignano Soc. Coop., Putignano, Italy. FDA initiated recall is complete.
REASON
FDA analysis detected the presence of E. coli (non-pathogenic) in the product lot.
VOLUME OF PRODUCT IN COMMERCE
107 cases (12 - 300 g units per case)
DISTRIBUTION
NY, NJ, CT
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS

PRODUCT
Ropinirole HCl a) 0.25mg 500-count bottle; b) 0.5mg 30-count bottle; c) 0.5mg 90-count bottle;d) 0.5mg 500count bottle; e) 1mg 500-count bottle; f) 2mg 500-count bottle
CODE
a) NDC 793-05 GSMS Lot #: 102795A 103611A, 103611B, 103612A, 103612B, 104441A, 104876A, 105558A; b) NDC 794-30 GSMS Lot #: 105202A; c) NDC 794-90 GSMS Lot #: 105202B;d) NDC 794-05 GSMS Lot #: 103537A, 103989B, 105027A, 105027B, 105559A, 105559B; e) NDC 795-05 GSMS Lot #: 102961A, 102962A, 102962B, 103668B, 104442A, 104878A, 105514A; f) NDC 796-05 GSMS Lot #: 103613A, 103613B, 103613C, 103613D, 104067A, 104067B, 104623A, 1055181
RECALLING FIRM/MANUFACTURER
Recalling Firm: Golden State Medical Supply Inc., Camarilla, CA
Manufacturer: Corepharma LLC, Middlesex, NJ
REASON FOR RECALL
Impurities/Degradation Products

PRODUCT
a) Heparin in 5% Dextrose Inj (40 U/mL) 500mL; b) Heparin in 5% Dextrose Inj (50U/mL) 500mL; c) Heparin in 5% Dextrose Inj (100U/mL) 250mL; d)Heparin in 0.9% Sodium Chloride Inj (2U/mL) 500mL
CODE
a) US Catalog code: P5671 Lot #: J1D638N, J1N645N Canadian Catalog code: P5671-00 Lot #: J1D614B, J1D698N; b) US Catalog code: P5771 Lot #: J1D587N Canadian Catalog code: P5771-00 Lot #: J1D629N, J1D695N, J1D697N; c) US Catalog code: P5872 Lot #: J1D703N Canadian Catalog code: P5872-00 Lot #: J1D630N, J1D631N, J1D702N; d) US Catalog code: P8721 Lot #: J1D575N, J1D639N, J1D650N, J1E534N, J1E544N, J1E695N, J1E705N, J1H522N, J1H523N, J1H590N, J1H591N, J1H601N, J1H602N, J1H625N, J1H634N, J1N724N, J1N737N, J1S474N, J1S545N. Canadian Catalog code: P5871-00 Lot #: J1J530N, J1K480N, J1K481N.
RECALLING FIRM/MANUFACTURER
Recalling Firm: B Braun Medical Inc, Irvine, CA
REASON FOR RECALL
OOS assay

PRODUCT
Midodrine Hydrochloride Tablets, 5mg, 100-count bottle, NDC 0185-0043-01,
CODE
Lot number: BT0643, Exp Date 06/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc. Princeton, NJ
Manufacturer: Sandoz Pharmaceuticals, Wilson, NC
REASON FOR RECALL
Rough appearance and legibility of the logo on some of the tablets
 
RECALLS AND FIELD CORRECTIONS:DRUGS - CLASS II

PRODUCT
Clonidine Transdermal System, USP 0.2 mg/day, 4 patches/carton, Rx only, NDC 0378-0872-99. Recall # D-1268-2012
CODE
Lot Number: 6C0074 Expiration June 2013
RECALLING FIRM/MANUFACTURER
Mylan Technologies, Inc., Saint Albans, VT, by letter beginning on February 24, 2012. Firm initiated recall is ongoing.
REASON
Defective Delivery System: Mechanical Peel Force yielded high OOS results.
VOLUME OF PRODUCT IN COMMERCE
38,469 cartons of pack of 4s
DISTRIBUTION
Nationwide

PRODUCT
1) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Original (16 fl. oz.) NDC#: 37000-032-04, SKUs 84806240 and 84804290. Recall # D-1271-2012;
 
2) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Cherry (12 fl. oz.) NDC#: 37000-475-12, SKU 84929877. Recall # D-1272-2012;
 
3) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Max Strength (12 fl. oz.) NDC#: 37000-019-03, SKUs 80216951 and 80216952. Recall # D-1273-2012
CODE
1) Lot Codes: 2017171953, Exp. Date: Dec-13 and 2017171981, Exp. Date: Dec-13;
2) Lot Code: 2018171951, Exp. Date: Dec-13;
3) Lot Codes: 2018171952, Exp. Date: Dec-13 and 2018171981, Exp. Date: Dec-13
RECALLING FIRM/MANUFACTURER
Procter & Gamble Co., Mason,OH, by letter on March 12, 2012.
Manufacturer: Procter & Gamble Manufacturing, Greensboro, NC. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: Out of Specification (OOS) result for Purified Water used to rinse product contact parts during manufacturing.
VOLUME OF PRODUCT IN COMMERCE
17,828 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS:DRUGS - CLASS III

PRODUCT
1) Squibb Kenalog Injection 10 (Triamcinolone Acetonide Injectable Suspension, USP), 50 mg/5 mL, 10 mg/mL, 5 mL multiple vial, Rx only, NDC 0003-0494-20. StrengthProduct/SAP Package/I Description NDC Expiration No. 10 mg/mL KENALOG SINJ 10MG/ML (1VL.X5ML) US 0003-0494-20 SEPT 2012. Recall # D-1269-2012;
 
2) Squibb Kenalog Injection 40 (Triamcinolone Acetonide Injectable Suspension, USP), 40 mg/mL, 10 mL multiple vial, Rx only, NDC 0003-0293-28, Strength Lot Number Product/SAP Package/I Description NDC Expiration No. 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X5ML) US 0003-0293-20 SEPT 2012,, 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X10ML) US 0003-0293-28 OCT 2012, 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X10ML) US 0003-0293-28 OCT 2012, 40 mg/mL KENALOG SINJ 40MG/ML (1VL.X10ML) US 0003-0293-28 OCT 2012, 40mg/mL KENALOG SINJ 40MG/ML (1VLX10ML) US 0003-0293-28 OCT 2012. Recall #D-1270-2012
CODE
1) OK65465 1131273;
 
2) OK66391 1131271; OK66412 1131272, OK66414 1131272, OK66501 1131272,OL56792 1131272
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb, Anagni, Italy, by letters dated October 21, 2011 and December 14, 2011. Firm initiated recall is ongoing.
REASON
Presence of Precipitate: Atypical particle size found in vial.
VOLUME OF PRODUCT IN COMMERCE
182,292 vials
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

PRODUCT
1) Trima Accel RBC + TLR Filter, Plasma Set, Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 777800550 and 80550. Recall # B-0612-12;
 
2) Trima Accel MultiPlasma Set, Made in USA, Expiry Date: 2013-11-01, Manufacture Date: 2011-11-01, Sterile/EO Ref 80700, Lot 11T1234, single use. Catalogue number 80700. Recall # B-0613-12;
 
3) Trima Accel RBC Plasma Set, Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80500 and 777800500. Recall # B-0614-12;
 
4) Trima Accel Auto RBC, Plasma Set, Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80520. Recall # B-0615-12;
 
5) Trima Accel Enhanced PPC, Plasma, RBC Set, Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80491 and 80490. Recall # B-0616-12;
 
6) Trima Accel Platelet + Flt Filter + Auto P.A.S., Plasma, RBC + TLR Filter Set, Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80484. Recall # B-0617-12;
 
7) Trima Accel LRS Platelet, Plasma, RBC + TLR Filter + Auto P.A.S. Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80480. Recall # B-0618-12;
 
8) Trima Accel Platelet + Auto P.A.S., Plasma, Auto RBC Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80470. Recall # B-0619-12;
 
9) Trima Accel PPC, Plasma, RBC + TLR Filter Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80460. Recall # B-0620-12;
 
10) Trima Accel Enhanced Platelet, Plasma, RBC Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80449 and 80440. Recall # B-0621-12;
 
11) Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80450 and 777800450. Recall # B-0622-12;
 
12) Trima Accel Enhanced Platelet, Plasma, RBC + Auto P.A.S. Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80420. Recall # B-0623-12;
 
13) Trima Accel Platelet + Sampler, Auto P.A.S., MultiPlasma, RBC Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80370. Recall # B-0624-12;
 
14) Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80410 and 80411. Recall # B-0625-12;
 
15) Trima Accel Platelet + Sampler, Plasma, Auto RBC Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80360. Recall # B-0626-12;
 
16) Trima Accel Platelet, Plasma, Auto RBC Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog number 80350. Recall # B-0627-12;
 
17) Trima Accel Enhanced Platelet, MultiPlasma, RBC Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80340, 80349. Recall # B-0628-12;
 
18) Trima Accel LRS Platelet, Plasma Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80300, 80301, 80330, and 80337. Recall # B-0629-12;
 
19) Trima Accel LRS Platelet, Plasma, RBC Set. Made in USA, Expiry Date: 2013-12-01, Manufacture Date: 2011-12-01, Sterile/EO, single use. Catalog numbers 80400, 777800400. Recall # B-0630-12
CODE
All lot numbers prior to January 2012 date of manufacture.
RECALLING FIRM/MANUFACTURER
Caridian BCT, Inc., Lakewood, CO, by letter dated January 25, 2012. Firm initiated recall is ongoing.
REASON
Trima Accel System Disposable Tubing Sets, with a potential for hemolysis due to possible bent return tubing in manifold, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,699,752 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0740-12
CODE
Unit: W141608451730
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter dated June 25, 2008. Firminitiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
Cryoprecipitated AHF. Recall #B-0743-12
CODE
Units: 06GW37151, 06LH00661, 06LH00663, 06LH00665, 06LH00666, 06LH00667, 06LH00681, 06LH00712, 06LH00713, 06LY65911, 06LY65913, 06LY65914
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on February 21, 2008. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured within the appropriate timeframe, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA

PRODUCT
Fresh Frozen Plasma. Recall # B-0753-12
CODE
Unit: W010007005620
RECALLING FIRM/MANUFACTURER
Department Of The Army, Armed Services Blood Bank Center,
Tacoma, WA, by facsimile on October 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

PRODUCT
Source Plasma. Recall # B-0769-12
CODE
Units: 0250086728; 0250086528; 0250086327 0250086077; 0250085930; 0250085648; 0250085512; 0250085105; 0250084989; 0250084614; 0250084515; 0250084179; 0250084112; 0250083581; 0250083476; 0250083151; 0250082869; 0250082518; 0250082418; 0250082101; 0250081449; 0250081330; 0250080847; 0250080616; 0250080464; 0250079429; 0250079281; 0250078892; 0250078748; 0250078429; 0250078247; 0250078029; 0250076884; 0250076722; 0250076388; 0250075993; 0250075850; 0250075558; 0250075401; 0250075113; 0250074975; 0250074472; 0250074138; 0250073964; 0250073594; 0250073437; 0250073100; 0250072967; 0250072579; 0250072452; 0250072207; 0250072051; 0250071788; 0250071676; 0250071172; 0250071020; 0250070336; 0250070272; 0250069881
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Pocatello, ID, by fax on November 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
CA and Spain

PRODUCT
1) Red Blood Cells. Recall # B-0774-12;
2) Cryoprecipitated AHF. Recall # B-0775-12;
3) Platelets. Recall # B-0776-12;
4) Plasma Frozen. Recall # B-0777-12;
5) Recovered Plasma. Recall # B-0778-12;
6) Fresh Frozen Plasma. Recall # B-0779-12
CODE
1) Units: W038509101220, W038508101073, 6043634, 1068371, 1067150, 1067656, 1064348, 1062449, 1060977, 1059582, 1058466, 1056063, 1054586, 1047919, 1045552;
 
2) Units: 6043634, 1068371, 1062449;
 
3) Units: W038509101220, 1064348, 1054586, 1067150;
 
4) Units: W038509101220, 1067150, 1067656;
 
5) Units: W038508101073, 6043634, 1068371, 1064348, 1063449, 1060977, 1059682, 1054586;
 
6) Units: 1058466, 1056063, 1047919, 1045552
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on July 8 and July 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
FL, GA, SC

PRODUCT
Fresh Frozen Plasma. Recall # B-0794-12
CODE
Unit: W141607378650
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on January 18, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
Platelets. Recall # B-0795-12
CODE
Unit: W141607594285
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by telephone on December 3, 2007.
Manufacturer: Puget Sound Blood Center and Program, Tukwila,WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0796-12;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0797-12
CODE
1) Units: LJ30698, LJ33272;
2) Units: LJ30698, LJ32651
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa,CA, by telephone June 30, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the drug Avodart/Dutasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

PRODUCT
Source Plasma. Recall # B-0818-12
CODE
Units: DU0576398, DU0576598, DU0577147, DU0577321, DU0578309, DU0578613, DU0579037, DU0579253, DU0579776, DU0580173, DU0580504, DU0580923, DU0581217, DU0581773, DU0582045, DU0582496, DU0582846, DU0585443, DU0586235, DU0587283, DU0587500, DU0588633, DU0589046, DU0593093, DU0595436, DU0595781, DU0596296, DU0596614, DU0597018, DU0597665, DU0598278, DU0598515, DU0598948, DU0599929, DU0600288, DU0600967, DU0601299, DU0602046, DU0602279, DU0603515, DU0614677, DU0615060, DU0615467, DU0615813, DU0616247, DU0616614, DU0617108, DU0617435, DU0617895, DU0618259, DU0618851, DU0619144, DU0619701, DU0620035, DU0620581, DU0620912, DU0621500, DU0621809, DU0622425, DU0622757, DU0623380, DU0623696, DU0624863, DU0625808, DU0626027, DU0628259, DU0629100, DU0630271, DU0630783, DU0631098, DU0631625, DU0632164, DU0632443, DU0633160, DU0633591, DU0633978, DU0634545, DU0634926, DU0635492, DU0635806, DU0636367, DU0636632, DU0637160, DU0637748, DU0638223, DU0638581, DU0639412, DU0639637, DU0640271, DU0640771, DU0641625, DU0641882, DU0642468, DU0642815, DU0643422, DU0643760, DU0644369, DU0644686, DU0647279, DU0647714, DU0648442, DU0648806, DU0649609, DU0650498, DU0650999, DU0651558, DU0652057, DU0652487, DU0653143, DU0653428, DU0654123, DU0654499, DU0655142, DU0655666, DU0656473, DU0656810
RECALLING FIRM/MANUFACTURER
DCI Plasma Center Of Duluth, LLC, Duluth, MN, by facsimile on January 22, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
116 units
DISTRIBUTION
UK

PRODUCT
1) Red Blood Cells. Recall # B-0827-12;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0828-12
CODE
1) and 2) Unit: W141607180810
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle,WA, by facsimile on January 31, 2008 and by letter on February 19, 2008.
Manufacturer: Puget Sound Blood Center and Program, Olympia, WA. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

PRODUCT
1) Red Blood Cells. Recall # B-0835-12;
2) Recovered Plasma. Recall # B-0836-12
CODE
1) and 2) Unit: Q20780
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile or electronic notification on February 9, 2006 and by letter dated April 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria

PRODUCT
Red Blood Cells. Recall # B-0838-12
CODE
Unit: Y05439
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on March 23, 2006 and by letter dated May 12, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0840-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0841-12
CODE
1) Units: 06LH80831 (2 units);
2) Unit: 06GW25952
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on August 10, 2007 and by letter dated August 10, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 unit
DISTRIBUTION
CA

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0843-12
CODE
Unit: 06FS06350
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on April 22, 2008 and by letter dated April 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0844-12
CODE
Unit: 06LQ71602
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Salt Lake CityUT, by telephone or electronic notification on September 26, 2008 and by letter dated September 26, 2008.
Manufacturer: The American National Red Cross, Pomona, CA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

PRODUCT
Recovered Plasma. Recall # B-0848-12
CODE
Unit: 6781613
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by electronic notification on September 19, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

PRODUCT
Red Blood Cells (Apheresis). Recall # B-0850-12
CODE
Unit: LF37207 (Part 2)
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on October 16, 2007. Firm initiated recall is complete.
REASON
Blood product, which had a low volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0852-12;
2) Red Blood Cells (Apheresis) Leukocytes Reduced Recall # B-0853-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0854-12
CODE
1) Units: 032GC62628, 032GC63335, 032GC63435, 032GC64368, 032GC64406, 032GC64418, 032GC64982, 032GC65252, 032GC66200, 032GC66542, 032GC67089, 032GC67093, 032GC67197, 032GC67198, 032GC67372, 032GC67478, 032GC67506, 032GC67984, 032GC67994, 032GC68018, 032GC68023, 032GE96466, 032GE96550, 032GE96563, 032GE96825, 032GE97766, 032GE98880, 032GE99296, 032GE99577, 032GG06500, 032GG06879, 032GG08185, 032GG08498, 032GG08582, 032GG09274, 032GG10144, 032GN70407, 032GN70425, 032GN70577, 032GN70578, 032GN71192, 032GN71292, 032GN71293, 032GN71573, 032GN71579, 032GN71588, 032GN71773, 032GN71820, 032GN72048, 032GN72347, 032GN72910, 032GN72929, 032GN73732, 032GN73737, 032GN73764, 032GN74304, 032GN75139, 032GN75152, 032GN75189, 032GN75340, 032GN75392, 032GN75984, 032GN76631, 032GN76652, 032GN77401, 032GN77929, 032GN77930, 032GN77958, 032GN78573, 032GN79180, 032GN79184, 032GN80049, 032GN79354;
 
2) Units: 032GH11155 (2 units), 032GH11257 (2 units), 032GH11506 (2 units), 032GH11562 (2 units), 032GH12228 (2 units);
 
3) Unit: 032GN71966
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on August 22, 2009, August 25, 2009, and March 23, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
Nationwide

PRODUCT
1) Red Blood Cells. Recall # B-0865-12;
2) Platelets. Recall # B-0866-12;
3) Fresh Frozen Plasma. Recall # B-0867-12
CODE
1), 2) and 3) Unit: 4021609
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on February 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA

PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0874-12
CODE
Units: 2110075-1; 2110075-2
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 5, 2007.
Manufacturer: Laboratories at Bonfils, Denver, CO. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

PRODUCT
Red Blood Cells (Apheresis). Recall # B-0880-12
CODE
Units: 5561197, 5866816, 5512150, 5667217
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on May 24, 2006 and a follow up fax on June 19, 2006.Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, which did not meet the required product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0881-12
CODE
Units: 84Q 39414, 84Q 42264, 84Q 44638
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated July18, 2007. Firm initiated recall is complete.
REASON
Blood products, lacking proper documentation of antigen typing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0892-12
CODE
Unit: 084J06400
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated August 29, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-0752-12
CODE
Unit: 21LC57619 (pool ID#15786)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on February 16, 2006 and by letter dated February 21, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

PRODUCT
Source Plasma. Recall # B-0755-12
CODE
Units: 367043709, 367043663
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Eugene, OR, by facsimile on August 22, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

PRODUCT
1) Plasma Frozen. Recall # B-0810-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0811-12
CODE
1) and 2) Unit: 01KJ60769
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, West Henrietta, NY, by telephone and facsimile on December 22, 2004.
Manufacturer: The American National Red Cross, Rochester, NY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking an antibiotic, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0817-12
CODE
Unit: 7789782
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York,NY, by facsimile on March 17, 2008.
Manufacturer: New York Blood Center, Inc., Westbury,NY. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

PRODUCT
Source Plasma. Recall # B-0819-12
CODE
Units: DU0684208, DU0684869, DU0685333, DU0686071, DU0686542, DU0687341, DU0687835, DU0688645, DU0689081, DU0689774, DU0690261, DU0691080, DU0691566, DU0692406, DU0692913, DU0693727, DU0694229, DU0694923, DU0695344, DU0695999, DU0696400, DU0697088, DU0697499, DU0698163, DU0698586, DU0699384, DU0700061, DU0700448, DU0701280, DU0701725, DU0702342, DU0702753, DU0703491, DU0703752, DU0705749, DU0708115, DU0708452, DU0711896, DU0712284, DU0716238, DU0718628, DU0719001, DU0720439, DU0720902, DU0721261, DU0721714, DU0722797, DU0723125, DU0723601, DU0724077, DU0724566, DU0724910, DU0725353, DU0725667, DU0726144
RECALLING FIRM/MANUFACTURER
DCI Plasma Center Of Duluth, LLC, Duluth, MN, by facsimile on April 20, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously deferred for testing positive for the human immunodeficiency virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
UK

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0820-12
CODE
Units: 021FT62052, 021FT62056, 021FT62065, 021FT62067
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by telephone on March 1, 2006 and by letter dated March 10, 2006. Firm initiated recall is complete.
REASON
Blood products, which were leukoreduced greater than five days after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OR

PRODUCT
Recovered Plasma. Recall # B-0837-12
CODE
Unit: V57401
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by electronic notification on February 27, 2006. Firm initiated recall is complete.
REASON
Blood product, for which the freezing step was performed incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

PRODUCT
Recovered Plasma. B-0839-12
CODE
Unit: 06GW25952
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on August 10, 2007 and by letter dated August 10, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

PRODUCT
Recovered Plasma. Recall # B-0842-12
CODE
Unit: 06FS06350
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on April 22, 2008 and by letter dated April 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

PRODUCT
Recovered Plasma. Recall # B-0845-12
CODE
Unit: 06LQ71602
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Salt Lake CityUT, by telephone or electronic notification on September 26, 2008 and by letter dated September 26, 2008.
Manufacturer: The American National Red Cross, Pomona, CA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0849-12
CODE
Units: 6246659 (2 units), 6246660, 6246661 (3 units), 6246662 (2 units), 6246665 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by letter dated October 18, 2006.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NY, NJ

PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0851-12
CODE
Unit: 06GG84787 (2 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona,CA, by telephone on October 29, 2007 and by letter dated December 10, 2007. Firm initiated recall is complete.
REASON
Blood products, for which the label was missing the product volume and anticoagulant volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0882-12
CODE
Units: Ql9295, Ql9233, Ql9252, G13867, G13879, Ql9245, G13908, G13870, G13890, 889072 ,889145 ,P55759 , 889108, 889056, Ql9259, V48669, V48676, V48682, V48686, V48654, V48655, V48656, V48666, T26520, T26519, S88222, S88223, S88229, S88237, V47842, V47862, V47813, V47863, V47879, V47893, P55612, P55619, R19133, R19134, R19139, R19146, R19150, T26493,T26495, T26504, T26509, T26513, T26514, T26517, T26502,T26508, T26512, V46960
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter on September 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet the specifications for leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
CA

PRODUCT
ORTHO ProVue System (Product Code MTS 213784), potentially configured with the Heron Datalogic D-130 Barcode Scanner. (Hand-Held only). Hand-held Heron Datalogic D-130 Barcode Scanner is labeled in part: "***HERON***DATALOGIC***" Located on underside of the scanner: "***10***N263***SA***Type: Heron D130 BLACK***5 VDC***180mA*** This device complies with PART 15 of the FCC. See manual for FCC details.***SEE PACKAGE FOR PATENT LISTING***CLASS 1 LED PRODUCT***" Coding below includes serial numbers for all systems distributed that have the potential to have the Heron Datalogic D-130 Barcode Scanner configured for use on the ORTHO ProVue Analyzer. Recall # B-0885-12
CODE
Units: 0571181223, 0571181229, 0571201241, 0571201247, 0571191232, 0571201244, 0571211256, 0571211254, 0571211258, 057P020117, 0571201245, 0571181222, 0571211252, 057P020122, 0571221260, 0571231272, 0571221262, 0571231273, 0571221268, 0571251291, 0571251293, 0571251297, 0571271311, 0571231278, 0571231275, 0571271317, 0571251299, 0571281320, 0571281321, 0571521556, 0571521557, 0571281322, 0571271310, 0571271314, 0571191234, 0571271316, 0571271315, 0571521561, 0571281328, 0571251298, 0571521558, 0571381416, 0571521560, 0571521559, 0571381418, 0571271318, 0571281329, 0571541581, 0571281325, 0571521564, 0571231277, 0571521562, 0571541579, 0571381422, 0571541583, 0571381421, 0571381423, 0571541576, 0571541585, 0571561602, 0571621661, 0571541580, 0571561601, 0571631670, 0571201249, 0571631673, 0571561598, 0571631671, 0571561604, 0571521565, 0571631675, 0571621656, 0571631674, 0571661705, 0571671707, 0571381419, 0571661701, 0571661696, 0571661700, 0571661697, 0571691730, 0571661703, 0571701742, 0571661699, 0571691729, 0571621658, 0571671714, 0571621660, 0571691731, 0571561597, 0571631669, 0571631668, 0571671715, 0571661704, 0571621663, 0571701739, 0571701736, 0571711754, 0571711755, 0571711747, 0571671710, 0571721757, 0571701740, 0571541584, 0571691734, 0571221267, 0571721763, 0571721758, 0571691728, 0571661702, 0571621662, 0571721761, 0571701737, 0571721762, 0571721760, 0571561605, 0571731774, 0571691733, 0571721756, 0571831870, 0571711752, 0571731769, 0571831867, 0571721764, 0571851888, 0571851886, 0571851883, 0571861896, 0571831871, 0571851884, 0571861894, 0571851885, 0571731775, 0571831868, 0571861898, 0571851891, 0571731773, 0571861900, 0571861899, 0571851890, 0571851882, 0571861901, 0571861895, 0571851889, 0571871903, 0571871902, 0571941976, 0571871911, 0571941980, 0571831869, 0571961998, 0571871908, 0571871904, 0571961997, 0571962000, 0571381424, 0571871909, 0571861893, 0571851887, 0571961996, 0571992028, 0571992024, 0571671706, 0572082116, 0571992027, 0571871905, 0572082119, 0571941977, 0572052090, 0572082115, 0572082118, 0572072106, 0571982014, 0572072102, 0572072107, 0572062097, 0572062099, 0572112150, 0572072105, 0571871910, 0572072109, 0572082117, 0572092131, 0572092130, 0572092126, 0572052088, 0572072108, 0572092125, 0572052091, 0572082121, 0572172211, 0572172209, 0572072103, 0572062100, 0572062101, 0572182220, 0572092122, 0572182218, 0572172210, 0572202233, 0572182215, 0572182216, 0572172206, 0572202239, 0572212242, 0571992022, 0572202238, 0572212244, 0572062098, 0572202240, 0572212243, 0572212249, 0572202235, 0572202241, 0572182217, 0572212248, 0572212247, 0572242274, 0572242272, 0572262295, 0572262293, 0572182214, 0572262296, 0572262301, 0572312348, 0572242277, 0572242278, 0571561596, 0571671709, 0572332366, 0572202232, 0572332364, 0572362394, 0572262297, 0572312346, 0572242280, 0572362393, 0572212245, 0572362395, 0572432467, 0572262299, 0572432465, 0572362398, 0572332362, 0571962001, 0572422458, 0572422459, 0572362392, 0572422460, 0572432469, 0572432471, 0572312349, 0572362400, 0572442476, 0572442479, 0572242275, 0572262292, 0572462493, 0572432468, 0572432464, 0572442478, 0572362396, 0572432470, 0572442472, 0572442477, 0572492526, 0573133002, 0573042958, 0573133006, 0572882878, 0573102988, 0573133003, 0573173024, 0573143007, 0573143008, 0573173023, 0573193032, 0573102991, 0572842858, 0573062971, 0573173026, 0573193034, 0573032955, 0572772802, 0573193035, 0573253062, 0573143009, 0573143010, 0573193033, 0573253063, 0573293086, 0573303091, 0573143011, 0573193036, 0573293084, 0573303087, 0573173022, 0573343107, 0573363117, 0573293085, 0573303088, 0573303089, 0573293082, 0573363120, 0572852865, 0572852866, 0572852863, 0572852864, 0572962918, 0573042959, 0572972923, 0573042960, 0572972926, 0573032952, 0573032953, 0572532570, 0572872872, 0573102990, 0572962917, 0573042961, 0573042957, 0572882879, 0573032956, 0573062968, 0572882881, 0573062969, 0572942907, 0573032954, 0573112992, 0573102987, 0572972924, 0572762795, 0573122998, 0573112996, 0573122997, 0573122999, 0573112995, 0573112994, 0573133005, 0573133004, 0573123001, 0573173025, 0572832854, 0572802840, 0572872874, 0572782813, 0572862870, 0572822847, 0572832852, 0572822849, 0572942911, 0572942910, 0572942908, 0572942909, 0572952914, 0572772810, 0572782815, 0572772811, 0572842859, 0572782812, 0572842860, 0572852862, 0572962920, 0572962919, 0572972925, 0572862869, 0572952915, 0572822851, 0572952916, 0572862868, 0572862871, 0572872873, 0572862867, 0572872875, 0572802837, 0572882880, 0572962921, 0572972922, 0572872876, 0572602635, 0572762798, 0572722755, 0572802833, 0572622661, 0572802832, 0572762799, 0572752785, 0572092123, 0572092124, 0572772809, 0572622659, 0572762796, 0572782816, 0572782820, 0572782821, 0572782817, 0572782819, 0572762793, 0572762792, 0572602639, 0572772806, 0572762800, 0572772808, 0572782818, 0572802834, 0572772804, 0572772805, 0572832856, 0572802838, 0572842861, 0572882877, 0572822850, 0572472509, 0572802835, 0572802841, 0572822848, 0572802839, 0572832853, 0572622655, 0572602637, 0572622654, 0572562598, 0572562597, 0572552586, 0572692729, 0572622653, 0572622658, 0572622657, 0572692731, 0572722759, 0572622660, 0572692728, 0572722756, 0572722760, 0572562595, 0572532571, 0572722754, 0572722758, 0572722753, 0572722757, 0572722761, 0572752782, 0572752786, 0572752783, 0572692730, 0572752787, 0571961999, 0572752788, 0572542574, 0572752784, 0572752791, 0572752789, 0572752790, 0572762801, 0572762794, 0571561600, 0572522558, 0572242281, 0572522561, 0572502538, 0572522560, 0572532565, 0572522557, 0572542575, 0572542576, 0572542573, 0572502541, 0572522556, 0572262300, 0572362401, 0572532567, 0572362399, 0572472507, 0572542581, 0572472506, 0572202234, 0572542579, 0572522559, 0572332363, 0572552585, 0572562594, 0572602632, 0572602633, 0572462496, 0572462497, 0572512543, 0572552583, 0572562599, 0572542577, 0572492528, 0572602636, 0572562600, 0572552584, 0572602634, 0572492525, 0572442473, 0572442481, 0572502532, 0572462495, 0572492530, 0572462501, 0572472502, 0572472504, 0572472505, 0572462494, 0572432466, 0572422461, 0572512551, 0572502539, 0572502537, 0572502540, 0572512549, 0572472510, 0572512544, 0572462498, 0572492522, 0572522553, 0572502535, 0572522552, 0572212246, 0572492523, 0572492529, 0572522555, 0572522554, 0572472503, 0572492527, 0571941978, 0572532569, 0572532568, 0572262298, 0572532566, 0572462492, 0573253064, 0573062967, 0572782814, 0573363121, 0573403137, 0573403140, 0573353113, 0573363118, 0573353115, 0573343110, 0573423147, 0573303090, 0573353114, 0573363119, 0573353112, 0573403138, 0573493184, 0573423150, 0573513193, 0573513192, 0573513195, 0573293083, 0573523200, 0571731771, 0573493185, 0573563221, 0573563219, 0573563218, 0573523199, 0571671711, 0573513194, 0572772807, 0573523197, 0573523198, 0573353116, 0573493186, 0572762797, 0573563217, 0571871906, 0573623248, 0573573223, 0573573222, 0573523201, 0573603237, 0573573226, 0573613245, 0573573224, 0573643260, 0573493182, 0573673275, 0573513196, 0573643259, 0573403139, 0571861897, 0572832855, 0572472511, 0573123000, 0573603240, 0573613243, 0573423148, 0573663270, 0573673274, 0573423151, 0573663268, 0573673273, 0572802836, 0573663269, 0573623251, 0573603239, 0570003361, 0573613242, 0573603241, 0573673272, 0573062970, 0573343109, 0570003341, 0573623250, 0570003340, 0570003339, 0570003360, 0573643257, 0570003378, 0570003359, 0570003380, 0570003377, 0570003379, 0570003444, 0573573225, 0573673276, 0570003358, 0570003440, 0573603238, 0570003441, 0570003381, 0570003447, 0570003442, 0570003443, 0570003448, 0570003449, 0570003461, 0570003462, 0570003451, 0573563220, 0570003460, 0573253066, 0570003450, 0570003454, 0570003520, 0570003530, 0570003452, 0570003531, 0570003524, 0570003463, 0570003533, 0572442474, 0570003534, 0570003532, 0573253065, 0573343111, 0570003543, 0570003547, 0570003548, 0570003545, 0570003546, 0570003544, 0573613244, 0573623247, 0573613246, 0573623249, 0570003554, 0570003446, 0570003549, 0570003540, 0570003583, 0570003580, 0570003568, 0570003541, 0570003584, 0570003578, 0570003556, 0570003600, 0570003575, 0570003582, 0570003579, 0570003569, 0570003585, 0570003581, 0570003577, 0570003599, 0570003603, 0570003557, 0570003587, 0570003567, 0570003555, 0570003558, 0570003595, 0570003559, 0570003566, 0570003598, 0570003589, 0570003588, 0570003604, 0570003542, 0570003625, 0570003597, 0570003596, 0571941981, 0570003615, 0570003657, 0570003656, 0570003619, 0570003627, 0570003617, 0570003628, 0570003550, 0570003629, 0570003674, 0570003576, 0570003523, 0570003659, 0570003602, 0570003618, 0570003721, 0570003658, 0570003626, 0570003666, 0570003669, 0570003720, 0570003670, 0570003680, 0570003655, 0570003683, 0570003718, 0570003673, 0570003717, 0570003667, 0570003671, 0570003672, 0570003586, 0570003719, 0571191236, 0570003684, 0570003665, 0570003722, 0570003616, 0570003723, 0570003801, 0570003668, 0570003737, 0570003738, 0570003805, 0570003819, 0570003792, 0570003804, 0570003736, 0570003739, 0570003794, 0570003779, 0570003808, 0570003790, 0570003715, 0570003800, 0570003755, 0570003803, 0570003815, 0570003793, 0570003791, 0570003850, 0570003852, 0570003816, 0570003844, 0570003854, 0570003817, 0570003757, 0570003778, 0570003818, 0570003843, 0570003836, 0570003842, 0570003830, 0570003831, 0570003838, 0571701744, 0570003832, 0570003756, 0570003834, 0570003835, 0570003806, 0572182219, 0570003855, 0570003859, 0570003840, 0570003841, 0570003775, 0570003858, 0570003776, 0570003885, 0570003857, 0570003777, 0570003759, 0570003802, 0570003856, 0570003809, 0570003807, 0570003851, 0570003906, 0570003914, 0570003886, 0570003907, 0570003889, 0570003909, 0572492524, 0572502536, 0570003888, 0570003932, 0570003905, 0570003910, 0570003911, 0570003913, 0570003930, 0570003921, 0570003924, 0570003920, 0570003942, 0570003923, 0570003724, 0570003922, 0570003934, 0570003933, 0570003943, 0570003947, 0570003949, 0570003912, 0570003941, 0570003946, 0570003931, 0570003940, 0570003948, 0570003944, 057P010108, 057P010109, 0571201240, 0571201246, 0571201248, 0571191231, 0571211251, 0571211259, 0571201243, 0571221266, 0571231270, 0571271313, 0571251294, 0571251295, 0571251290, 057P010105, 0571521563, 0571541582, 0571561603, 0571631666, 0571631667, 0571621659, 0571711751, 0571621657, 0571671712, 0571701738, 0571711746, 0571711748, 0571711749, 0571711750, 0571731766, 0571731767, 0571831866, 0571941972, 0571941973, 0571941975, 0571941974, 0571721759, 0572072111, 0572172202, 0572112151, 0572172204, 0572112145, 0572112143, 0572112144, 0572172203, 0572172205, 0572172207, 0572172208, 0572112146, 0572112147, 0572112149, 0572182221, 0572602641, 0572242276, 0572312350, 0572312351, 0572542572, 0572492531, 0572542578, 0572952913, 0571191235, 0573112993, 0573423149, 0573643258, 0573102989, 0573343108, 0573663267, 0573663271, 0570003337, 0570003338, 0570003357, 0570003522, 0572442475, 0570003551, 0570003552, 0570003553, 0570003601, 0570003682, 0570003716, 0570003681, 0570003735, 0570003839, 0570003945, 0570003445, 0570003833, 0570003837
RECALLING FIRM/MANUFACTURER
Micro Typing Systems, Inc., Pompano Beach,FL, by letter dated July 20, 2011. Firm initiated recall is ongoing.
REASON
Ortho ProVue Analyzers (Product Code MTS213784), when used with Heron Datalogic D-130 Barcode Scanners (Hand-held only), associated with potential barcode reader errors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
191 scanners configured; 17 scanners potentially configured; 918 Ortho ProVue Analyzers potentially configured with Heron Datalogic D-130 Barcode Scan
DISTRIBUTION
Nationwide, PR, and Canada
 
RECALLS AND FIELD CORRECTIONS:DEVICES – CLASS II

PRODUCT
Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- COMMON/USUAL NAME - Continuous flush catheter; CLASSIFICATION NAME: Continuous flush catheter; Device Listing # D069932 Benephit Infusion Systems are intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. The Benephit Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit Infusion Systems are also indicated to facilitate TRT in patients who have demonstrated symptoms of acute kidney injury, and whom arterial catheterization for TRT is feasible. Recall # Z-0509-2012
CODE
Lot: C23415
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham,NY, by dated December 2, 2011.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
The Benephit XT Infusion System may contain hairline cracks in the sheath hub.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
Nationwide

PRODUCT
Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography. Recall # Z-0936-2012
CODE
Software release: PBL 6.1.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter on January 9, 2012.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
The skin dose and skin dose rate values are calculated using an incorrect point of reference. Therefore, the AKR as displayed and stored in patient records is too low, although the dose as received by the patient is not affected.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide

PRODUCT
Bravo pH Monitoring capsule, UPC 7290101361695, a) FGS# 0312 (5 pack) and UPC 7290101361688, b) FGS# 0313 (single). Product Usage: The Bravo pH Monitoring System is intended to be used for gastro esophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. Recall # Z-0966-2012
CODE
a) Lot numbers: 11775Q, 12064Q, 12227Q, 12333Q, 12389Q, 12440Q, 12475Q, 12494Q, 12643Q, 12545Q, 12769Q, 12770Q, 12840Q, 12896Q, 12897Q, 12928Q, 12989Q, 13026Q, 13056Q, 13109Q, 13109Q, 13162Q, 13164Q, 13208Q, 13233Q, 13246Q, 13282Q, 13283Q, 13371Q, 13390Q, 13462Q, 13461Q, 13540Q, 13569Q, 13634Q, 13679Q, 13695Q, 13700Q, 13712Q, 13716Q, 13753Q, 13777Q, 13786Q, 13798Q, 13799Q, 13813Q, 13836Q, 13867Q, 13894Q, 13937Q, 13979Q, 14064Q, 14101Q, 14120Q, 14141Q, 14230Q, 14255Q, 14265Q, 14284Q, 14338Q, 14400Q, 14419Q, 14423Q, 14458Q, 14491Q, 14542Q, 1457QQ, 14572Q, 14570Q, 14611Q, 14634Q, 14734Q, 14770Q, 14805Q, 14825Q, 14826Q, 14871Q, 15030Q, 15051Q, 15071Q, 15078Q, 15114Q, 15158Q, 15221Q, 15324Q, 15406Q, 15401Q, 15500Q, 15603Q, 15630Q, 15672Q, 15679Q, 15711Q, 15787Q, 15860Q, 15912Q, 15938Q, 15971Q, 15998Q, 16115Q, 16144Q, 16192Q, 16221Q, 16320Q, 16290Q, 16354Q, 16382Q, 16395Q, 16449Q, 16503Q, 16511Q, 16580Q, 16606Q, 16607Q, 16673Q, 16762Q, 16867Q, 16762Q & 16847Q and FGS-0313; b) Lot numbers: 12647Q, 12765Q, 12797Q, 12902Q, 13234Q, 13458Q, 13608Q, 13632Q, 13635Q, 13751Q, 13868Q, 13907Q, 14011Q, 14065Q, 14231Q, 14339Q, 14402Q, 14612Q, 14761Q, 14783Q, 14865Q, 14984Q, 15222Q, 15538Q, 15698Q, 15766Q, 15937Q, 16392Q, 16194Q, 16398Q, 16707Q, 16879Q, 17058Q & 16912Q
RECALLING FIRM/MANUFACTURER
Recalling Firm: Given Imaging Ltd., Norcross, GA, by letter on January 11, 2012.
Manufacturer: Given Imaging Ltd, Yokneam, Israel. Firm initiated recall is ongoing.
REASON
Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.
VOLUME OF PRODUCT IN COMMERCE
21,885 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
1) DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO GIA Universal Staplers with DUET TRS Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. Recall # Z-0991-2012;
 
2) DUET TRS 45 3.5MM ARTICULATING SULU Product Code: DUET4535A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. Recall # Z-0992-2012;
 
3) DUET TRS 45 4.8MM STRAIGHT SULU Product Code: DUET4548 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. Recall # Z-0993-2012;
 
4) DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. Recall # Z-0994-2012;
 
5) DUET TRS 60 3.5MM STRAIGHT SULU Product Code: DUET6035 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. Recall # Z-0995-2012;
 
6) DUET TRS 60 3.5MM ARTICULATING SULU Product Code: DUET6035A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. Recall # Z-0996-2012;
 
7) DUET TRS 60 4.8MM STRAIGHT SULU Product Code: DUET6048 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. Recall # Z-0997-2012;
 
8) DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. When used with the ENDO GIA Universal and Ultra Staplers, the Duet TRS Reloads with Biosyn tissue reinforcement place two, triple-staggered rows titanium staples while simultaneously dividing the tissue and anchoring the preloaded Biosyn reinforcement material. The preloaded reinforcement material Is fully detached from the SULU upon complete firing of the length of the cartridge. The Duet TRS reinforcement material (Biosyn) is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. Recall # Z-0998-2012
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Covidien LP, North Haven, CT, by letter dated January 12, 2012. Firm initiated recall is ongoing.
REASON
Duet TRS Straight and Articulating Single Use (SULU) Loading Staplers used in thoracic surgery may result in serious injury or death.
VOLUME OF PRODUCT IN COMMERCE
671,977 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
S1827 Crea Calibration solution 1, 944-135, Product Usage: The S1827 Crea Calibration Solution 1 Part Number 944-135, is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters. Recall # Z-1008-2012
CODE
Lot: DV02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake,OH, by letter dated December 28, 2011.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results.
VOLUME OF PRODUCT IN COMMERCE
7 boxes/6/175 mL bottles
DISTRIBUTION
Nationwide

PRODUCT
1) TSX-301A: AQUILION ONE; System, X-Ray, Tomography. Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE, Toshiba's top of the line X-ray CT system, is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation. Recall # Z-1034-2012;
 
2) TSX-301B: AQUILION ONE; System, X-Ray, Tomography. Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition, the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE, Toshiba's top of the line X-ray CT system, is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation. Recall # Z-1035-2012
CODE
1) Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2123, 2131, 2133, 2139, 2143, 2148, 2151, 2158, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2174, 2208, 2211, 2212, 2219, 2220, 2222, 2241, 2253, 2257, 2265, 2275, 2283, 2284, 2291, 2294, 2308, 2311, 2316, 2324, 2328, 2332, 2333, 2006, 2007, 2008, 2011, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2025, 2027, 2030, 2031, 2032, 2033, 2035, 2002, 2004;
 
2) Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 2072, 2077, 2080, 2092, 2115, 2116, 2123, 2131, 2133, 2139, 2143, 2148, 2151, 2158, 2161, 2162, 2165, 2167, 2168, 2169, 2170, 2174, 2208, 2211, 2212, 2219, 2220, 2222, 2241, 2253, 2257, 2265, 2275, 2283, 2284, 2291, 2294, 2308, 2311, 2316, 2324, 2328, 2332, 2333, 2006, 2007, 2008, 2011, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2025, 2027, 2030, 2031, 2032, 2033, 2035, 2002, 2004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin,CA, by letter on January 3, 2012.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
The recall was initiated because Toshiba has confirmed that there is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One.
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
Nationwide and Puerto Rico

PRODUCT
1) "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***" Stainless steel stylet for ventricular catheter. Recall # Z-1047-2012;
 
2) "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***" Needle for lumbar peritoneal shunt. Recall # Z-1048-2012;
 
3) "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***" Collars for lumbar peritoneal shunt. Recall # Z-1049-2012;
 
4) "***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***" Needle for lumbar peritoneal shunt. Recall # Z-1050-2012;
 
5) "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047", Large OD .058" Step down connector to be secure with ligature. Recall # Z-1051-2012
CODE
1) Units: 1010344, 1011451, 1021637, 1030061, 1032742, 1040738, 1041561, 1052595, 1053121, 1053487, 1080115, 1080148, 1081155, 1082137;
 
2) Units: 1010046, 1010346, 1010779, 1011037, 1011159, 1011277, 1011590, 1021465, 1030665, 1031019, 1031525, 1070018, 1071032, 1072560, 1073567, 1083958;
 
3) Units: 1021597, 1031020, 1071033, 1092906, 1094646, 1100128, 1101134;
 
4) Units: 1030725, 1032722, 1040610, 1041158, 1041360, 1042200, 1050184, 1052919, 1052985, 1060593, 1060778, 1060985, 1061498, 1061571, 1061831, 1062078, 1084389, 1090768, 1092765;
 
5) Units: 1011261, 1020752, 1020887, 1021660, 1030180, 1031438, 1031740, 1041562, 1042443, 1050389, 1050897, 1052789, 1052981, 1053298, 1061717, 1072920, 1073554, 1081985, 1082859, 1090536, 1091830, 1092604
RECALLING FIRM/MANUFACTURER
Integra Neurosciences PR, Inc., Anasco,PR, by letter dated November 28, 2011. Firm initiated recall is ongoing.
REASON
The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
VOLUME OF PRODUCT IN COMMERCE
1,303 units
DISTRIBUTION
Nationwide and Austria, Canada, Italy, Australia

PRODUCT
GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution, high signal-to-noise ratio, with short scan times. The Signa Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa" Excite system with Surgical Option reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The GE Signa" Excite system with Surgical Option can provide MR images at various stages of a surgical procedure, and provides the capability to transfer a patient to the MR system table directly from a surgical table, or patient transport system. Images can be obtained using the MR scanner body coil, or local surface coils, and the surface coils used with the integrated system may/can accommodate sterile draping for surgical procedures. Recall # Z-1067-2012
CODE
12051M69 12228M63
RECALLING FIRM/MANUFACTURER
GE Medical Systems LLC, Waukesha, WI, by letter dated December 15, 2011. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of a potential safety issue due to the failure of the transfer board release lever associated with the OR Compatible patient transfer table of your Optima MR450w MR Surgical Suite.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide and Austria

PRODUCT
Retcam3 & Retcam Shuttle with version 6.0 software. General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. Model number RC3, part number 21-100500; Model number RCS, part number 20-000300. Recall # Z-1099-2012
CODE
Version 6.0 software
RECALLING FIRM/MANUFACTURER
Clarity Medical Systems Inc., Pleasanton, CA, by letter dated February 7, 2012. Firm initiated recall is ongoing.
REASON
Still images extracted from video recordings may be mislabeled as to right and left eye.
VOLUME OF PRODUCT IN COMMERCE
33 RetCam Shuttles and 20 RetCam3
DISTRIBUTION
Nationwide and Internationally`
 
RECALLS AND FIELD CORRECTIONS:DEVICES – CLASS III

PRODUCT
BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Venous Catheter and Peel-Apart Introducer Kit. Product Number: 0607173. Subcutaneous implanted intravascular infusion port and catheter is used to provide repeated access to the vascular system for the delivery of medications, intravenous fluids, parenteral nutrition solutions, and blood products. They are also indicated for the withdrawal of blood samples. Recall # Z-1133-2012
CODE
Lot Numbers: RESF0856, RESH0067, RESH1150
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Salt Lake City,UT, by letters on February 16, 2012 and on February 20, 2012.
Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Tamaulipas, Mexico. Firm initiated recall is ongoing.
REASON
The end flap label on the kit incorrectly describes the product as "Bard Port" MRI DUAL Implanted Port instead of a "Bard Port MRI Implanted Port" as correctly indicated on the main label of the kit.
VOLUME OF PRODUCT IN COMMERCE
545 units
DISTRIBUTION
Nationwide and Belgium
END OF ENFORCEMENT REPORT FOR MARCH 21, 2012,
 
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