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U.S. Department of Health and Human Services

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Enforcement Report for Aprl 27, 2005

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

April 27, 2005
05-17

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Camelot Desserts Caramel Apple Cheese Streussel Mini Pie, 8.5 oz. (240g), UPC 7 15432 42571 9. Recall # F-272-5.
CODE
All lot codes manufactured prior to initiation of the recall, 4339, 4346, 4352, and 4357. Lot codes are not identified on retail packaging. Mini Pies produced following the recall will contain lot codes on the retail packaging.
RECALLING FIRM/MANUFACTURER
CGI Desserts, Inc, Sugar Land, TX, by telephone and email on January 11, 2004, and by press release on January 14, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE 
624 cases of 9 units.
DISTRIBUTION 
NY, NJ, PA, MD, CT, and DE.

______________________________
PRODUCT
Salt Cured Herring packaged in 5 gallon white plastic buckets. To be weighed at point of sale. The fish are approx. 12 inches in length. Recall # F-273-5.
CODE
Uncoded .
RECALLING FIRM/MANUFACTURER
New York Fish, Inc., Brooklyn , NY , by press release on February 15, 2005 , followed by letter on February 16, 2005 . Firm initiated recall is complete.
REASON
The product is an uneviscerated processed fish based on inspectional findings by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE 
Unknown.
DISTRIBUTION 
NY.

_______________________________
PRODUCT
a) GANO Café 3-In-1 KOPI DENGAN PATI GANODERMA INSTANT COFFEE BEVERAGE WITH GANODERMA EXTRACT NET WEIGHT: 20 SACHETS X 21GM (0.741 OZ)*** GANO CAFÉ is an unique blend of refined ganoderma extract and high quality coffee of unique flavor. Product is packaged in cardboard box. Recall # F-274-5;
b) GANOCAFE ginseng Tongkat Ali***/Net Weight: ± 23 gm(± 0.81 oz) X 15 sachets**. GTA 1027 MAR 2006. Product is packaged in cardboard box. Recall # F-275-5;
c) “GANOC” REAL Spirulina Oats Net Weight: 30gm (1.06oz) X 15 sachets ***GCSO 0016 JAN 2006*** ***GANOC REAL SPIRULINA OATS -- A HEALTHY START FOR A HEALTHY LIFE Enriched with Ganoderma Lucidum Extract, Spirulina, Oats, Non-dairy Creamer and Sugar. Nutritious food suitable for the whole family. Product is packaged in cardboard box. Recall # F-276-5.
CODE
All lot numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gano Excel USA, Inc., Irwindale , CA , by letter and press release beginning on February 8, 2005 .
Manufacturer: GANO EXCEL INDUSTRIES SDN.BHD. (540854-H) 94, 95, 96, Kaw. Perusahaan Tandop Baru, Jln. Tunku Abdul Rahman, Kedah , Malaysia . Firm initiated recall is ongoing.
REASON
The product contains undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE 
Not determined.
DISTRIBUTION 
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
a) Pramosone Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%) Net Wt. in 1 oz (28.4 g) tubes, Rx only, NDC 0496-0716-04. Recall # D-192-5;

b) Pramosone Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Net Wt. 1 oz (28.4 g) and 2 oz (57 g) tubes, Rx only, NDC 0496-0717-03 and 0496-0717-04. Recall # D-193-5;

c) Analpram HC Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%) Net Wt. 1 oz tubes, Rx only, NDC 0496-0778-04. Recall # D-194-5;

d) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Net Wt. 1 oz tubes, Rx only, NDC 0496-0800-04. Recall # D-195-5.
CODE
a) Lots 03068A, exp. 03/05 and 04026A, exp. 02/06;
b) Lots 03071A, exp. 04/05; 03152A, exp. 08/05; lot 03169A, exp. 08/05 and 04024A, exp. 01/06;
c) Lot 03202, exp. 10/05;
d) Lots 03228A, exp. 10/05; 03232A, exp. 10/05; 03233A, exp. 1/0/05; 03234A, exp. 10/05; 03236A, exp. 10/05; 04001A, exp. 01/06 and 04002A, exp. 01/06.

RECALLING FIRM
Ferndale Laboratories, Inc., Ferndale, MI, by letters dated March 18, 2005. Firm initiated recall is ongoing.
REASON
Superpotent; pinhole defects in tubes may cause product to dry out and become more concentrated.
VOLUME OF PRODUCT IN COMMERCE 
180,461 tubes.
DISTRIBUTION 
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Part B. Recall # B-0856-5.
CODE
Unit 0891463.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson , TN , by telephone on September 3, 2003 . Firm initiated recall is complete.
REASON
Platelets, implicated in a transfusion reaction and contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
TN.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-0900-5.
CODE
Units: 04RMIC4718, 04RMIC4439, 04RMIC4040, 04RMIC3793, 04RMIC3348, 04RMIC3076, 04RMIC2658, 04RMIC2420, 04RMIC0800, 04RMIC0562, 04RMIC0147, 04RMIB9903, 04RMIB9488, 04RMIB9228.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Kentwood , MI , by fax on November 23, 2004 . Firm initiated recall is complete.
REASON
Problem: Blood products, collected from a donor who reported self-removal of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
14 units.
DISTRIBUTION 
NC.

______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0932-5.
CODE
Unit: 19GY15826.
RECALLING FIRM
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on June 14, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of contaminated platelets, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0946-5.
CODE
Unit: 26FG18421.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Gulf Coast Region, Mobile, AL, by telephone and follow-up letter on November 7, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm preparation was inadequate, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
AL.

_______________________________
PRODUCT
Platelets Pheresis, Leucocytes Reduced. Recall # B-0947-5.
CODE
Units: 04KE43718-1, 04KE43718-2 ( Split product).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on October 13, 2004 and by follow-up letter on October 15, 2004. Firm initiated recall is complete.
REASON
Blood Products, collected in a manner that may have compromised sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units.
DISTRIBUTION 
MA.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-0964-5;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0965-5.
CODE
a) Unit numbers: 19GL48123 (part 1 and 2),
19GL47879, 19GL47962 (part 1 and 2), 19GL48179 (part 1),
19GL48095 (part 1 and 2), 19GL47965 (part 2), 19GL47954 (part 1),
19GL47904 (part 1 and 2), 19GL47897 (part 1), 19GL47829 (part 2),
19GL48025 (part 1), 19GL47946 (part 1), 19GL47884 (part 1 and 2),
19GL48132 (part 1), 19GL48069 (part 1), 19GL48042 (part 1 and 2),
19GL48176 (part 1), 19GL48026 (part 1 and 2),
19GL48127 (part 1 and 2), 19GL48148 (part 1), 19GL47936 (part 1),
19GL49045 (part 1), 19GL48205 (part 1 and 2), 19GL48199 (part 1 and 2),
19GL48063 (part 1), 19GL48039 (part 1), 19GL47887 (part 1);
b) Unit numbers: 19GL48139, 19GL47881 (part 1 and 2),
19GL47832, 19GL48190, 19GL48025 (part 2),
19GL47940, 19GL47905, 19GL47829, 19GL48052 (part 1 and 2),
19GL47965 (part 1).
RECALLING FIRM/MANUFACTURER
American Red Cross, Tennessee Valley Region, Nashville, TN, by letter, dated December 24, 2003. Firm initiated recall is complete.
REASON
Platelet Pheresis products, lacking monthly quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
49 units.
DISTRIBUTION 
TN, and AR.

_______________________________
PRODUCT
Human Cornea Tissues for Transplantation. Recall # B-0971-5.
CODE
Tissues 012-04-183, 012-04-184.
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville , TN , by telephone on February 21, 2005 . Firm initiated recall is complete.
REASON
Human corneas, procured from a donor who tested repeatedly reactive for the antibody to hepatitis B core antigen (anti- HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 tissues.
DISTRIBUTION 
TN, and Jordan.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0974-5.
CODE
Unit number: 008716.
RECALLING FIRM/MANUFACTURER
United States Blood Bank, Inc., Miami , FL , by letter, on May 19, 2000 . Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with coagulase-negative, Staphylococcus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
FL.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced, Irradiated. Recall # B-0906-5.
CODE
Units: 19GN88031, 19GJ78567, 19GJ78559, 19GF11239, 19GN88016, 19LY56019, 19LY56005, 19LY56026, 19GN88042, 19GJ78558, 19GJ78578, 19LY56033.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on May 4, 2001 and letter on May 17, 2001. Firm initiated recall is complete.
REASON
Blood products, that were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
12 units.
DISTRIBUTION 
KY.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Irradiated. Recall # B-0908-5.
CODE
Units: 19GF29894, 19LW21464, 19LQ31612.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on February 11, 2002 and letter on February 12, 2002. Firm initiated recall is complete.
REASON
Blood products, that were out of controlled storage for more than 30 minutes, were distributed
VOLUME OF PRODUCT IN COMMERCE 
3 units.
DISTRIBUTION 
TN.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced, Irradiated. Recall # B-0909-5.
CODE
Units: 19GL40204, 19GL40209.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on December 17, 2001 and letter on December 21, 2001. Firm initiated recall is complete.
REASON
Blood products, that were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units.
DISTRIBUTION 
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0945-5
CODE
Unit: 19LW37687.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone on February 19, 2002. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low percent red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit.
DISTRIBUTION 
TN.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0949-5.
CODE
Unit numbers: 12LG21096, 12LG22405.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on September 2, 2003, and by letter, dated September 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of spherocytosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units.
DISTRIBUTION 
NC.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0966-5;
b) Fresh Frozen Plasma. Recall # B-0967-5.
CODE
a) and b) Unit 19LT05640.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and by letter dated June 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving information concerning post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units.
DISTRIBUTION 
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0972-5.
CODE
Unit numbers: 027LC42217, 027LC42226, 027LC42232, 027LC42245, 027LC42247, 027LC42250, 027LC42255, 027LC42258, 027LC42260, 027LC42263, 027LC42264, 027LC42267, 027LC42269, 027LC42270, 027LC42273, 027LC42275, 027LC42283, 027LC42286, 027LC42290, 027LC42294, 027LC42297, 027LC42299.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on October 18, 2004, and by letter, dated October 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected using trip scales that lacked quality control documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
22 Units.
DISTRIBUTION 
MD, WV, and PA.

_______________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-0975-5;b) Fresh Frozen Plasma Pheresis. Recall # B-0976-5.
CODE
a) Units 19GF53293 (Part 1, Part 2, and Part 3);
b) Units 19GL46438, 19GL46443, 19GT32085 ,19LP09584, 19LP09586.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and by letter dated June 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
8 units.
DISTRIBUTION 
AL, KY, and TN.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Bloom DTU-215-B Programmable Stimulator. Recall # Z-0713-05.
CODE
All Bloom DTU-215-B Programmable Stimulators.
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corporation, Denver , CO , by letter on January 13, 2005 . Firm initiated recall is ongoing.
REASON
Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
VOLUME OF PRODUCT IN COMMERCE 
712 units.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________
PRODUCT
a) Site-Rite Sterile Needle Guide Kit – 18 gauge.
Product Code 9001C0212. Recall # Z-0714-05;
b) Site-Rite Sterile Needle Guide Kit – 20 gauge.
Product Code 9001C0214. Recall # Z-0715-05;
c) Site-Rite Sterile Needle Guide Kit – 21 gauge.
Product Code 90013B01. Recall # Z-0716-05;
d) Site-Rite Sterile Ultrasound Probe Cover with Gel.
Product Code 9001C0197. Recall # Z-0717-05;
e) Intraoperative Ultrasound Cover Kit.
Product Code 900023B01. Recall # Z-0718-05;
f) Ultra/Phonic Conductivity Gel, 20 ml, each unit is a oil to foil pouch. Product is packaged 25 pouches per box. Product Code 9001C0200. Recall # Z-0719-05.
g) Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. Recall # Z-0720-05.
CODE
a) Lot numbers: 61208, 61233, 61258, 61287, 61308, 63189,

63220, 63225, 63263, 63305, 63338, 63360, 63383, 63402,

63414, 63442, 63472, 63515, 63530, 63564, 63597, 63646,

63720, 63766, 63783, 63817, 63845, 63875, 63924, 63953,

63991, 64056, 64063, 64125, 64164, 64191, 64258, 64261,

64269, 64330, 64364, 64401, 64420, 64433, 64448, 64452,

64514, 64652;

b) Lot numbers: 61187, 61233, 61258, 61302, 61332, 63189,

63220, 63245, 63270, 63339, 63360, 63398, 63401, 63402,

63422, 63451, 63515, 63521, 63538, 63564, 63612, 63615,

63666, 63729, 63766, 63783, 63830, 63862, 63925, 63957,

63973, 64042, 64094, 64108, 64148, 64182, 64218, 64229,

64258, 64261, 64268, 64378, 64419, 64420, 64440, 64460,

64493;

c) Lot Numbers 61189, 61219, 61280, 61302, 61332, 63141,

63147, 63171, 63245, 63262, 63339, 63360, 63401, 63421,

63422, 63450, 63451, 63521, 63538, 63590, 63615, 63666,

63723, 63729, 63770, 63814, 63830, 63862, 63913, 63925,

63991, 63998, 64028, 64063, 64080, 64137, 64151, 64192,

64218, 64229, 64261, 64289, 64330, 64353, 64375, 64401,

64447, 64492, 64550, 64591;

d) Lot numbers 61177, 61189, 61211, 61219, 61250, 61280,

61293, 61304, 63141, 63147, 63200, 63210, 63235, 63269,

63304, 63324, 63357, 63372, 63375, 63398, 63409, 63421,

63442, 63450, 63458, 63494, 63505, 63533, 63558, 63559,

63584, 63590, 63616, 63634, 63685, 63723, 63750, 63782,

63798, 63824, 63846, 63895, 63913, 63933, 63952, 63981,

64006, 64024, 64028, 64029, 64053, 64079, 64094, 64109,

64126, 64137, 64147, 64148, 64163, 64183, 64205, 64206,

64220, 64228, 64236, 64257, 64290, 64305, 64317, 64318,

64329, 64351, 64352, 64376, 64377, 64400, 64434, 64459,

64512, 64540, 64586, 64606, 64645, 64646;

e) Lot numbers 61233, 63200, 63235, 63263, 63270, 63324,

63357, 63375, 63401, 63409, 63414, 63451, 63458, 63515,

63530, 63559, 63612, 63615, 63646, 63674, 63770, 63824,

63875, 63953, 63998, 64080, 64191, 64258, 64269, 64289,

64317, 64493, 64586, 64646;

f) Lot Numbers 021404-4, 010904, 091403, 060303, 050403,

011003, 071202, 111300, 120998, 021202, 100101, 112703,

011202, 091398, 080900, 060500;

g) Site Rite II System - Item Numbers: 9740001-9740006.

Serial number ranges: 32563-32624, 33450-33549,

35900-35999, 37300-37399, 37950-38028.

Site Rite 3 System - Item Numbers: 9740010-9740019.

Serial number ranges: 32774-32974, 34900-35149,

36100-36199, 36450-36510, A02001-A02383.

Site Rite IV System - Item Numbers: 9740050-9740052,

9740059, 9740091, 9760004, 9760018. Serial number ranges:

B03001-B03588, B03590-B03601, B03603-B03607, B03609,

B03632, B03636, B03647.

RECALLING FIRM
Bard Access Systems, Inc., Salt Lake City , UT , by letter on October 4, 2004 and October 15, 2004 . Firm initiated recall is complete.
REASON
Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
VOLUME OF PRODUCT IN COMMERCE 
241,180 units.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________
PRODUCT
Shiley FlexTra brand Flexible Dual- Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed. Recall # Z-0721-05.
CODE
All codes are affected.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nellcor Puritan Bennett, Pleasanton , CA , by letters on December 3, 2004 . Manufacturer: MMJ S.A. De C.V., Cuidad Juarez, Mexico. Firm initiated recall is complete.
REASON
Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
VOLUME OF PRODUCT IN COMMERCE 
Approx. 17,056 units.
DISTRIBUTION 
Nationwide and Internationally.

_______________________________
PRODUCT
Allen A-91000 Shoulder Positioner. Recall # Z-0722-05.
CODE
Serial Numbers: 260227 260228 260229 260230 262208 A032121 A032122 A032123 A032124 A032125 A032126 A032128 A032129 A032340 A032942 A032944 A033038 A033039 A033040 A033920 A033921 A033922 A033923 A033924 A033925 A033927 A033928 A033929 A034241 A034242 A034243 A034623 A034624 A034626 A034627 A034628 A034877 A034907 A034909 A035239 A035242 A035243 A035623 A035624 A035625 A037489 A040087 A040359 A040360 A040361 A040362 A040363 A040364 A040650 A040693 A040694 A040778 A040779 A040780 A040781 A040782 A041742 A041743 A041744 A041745 A041746 A041747 A042080 A042081 A042082 A042159 A042533 A042534 A042640 A042641 A043683 A043684 A043953.
RECALLING FIRM/MANUFACTURER
Allen Medical Systems, Acton, MA, by letter dated March 4, 2005. Firm initiated recall is ongoing.
REASON
Shoulder positioner may break near the rail that attaches to the operating table.
VOLUME OF PRODUCT IN COMMERCE 
78 units.
DISTRIBUTION 
Nationwide, Australia , Greece , Italy , and Ireland .

_______________________________
PRODUCT
Intuitive Surgical da Vinci 8 mm Endo Wrist Curved Scissors, in box. FDA Device Listing Number R100529, Model Number 400178-01.510(k) number K021036. Recall # Z-0723-05.
CODE
All lots. P/N 400178-01.
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc, Sunnyvale , CA , by letters on March 9, 2005 . Firm initiated recall is ongoing.
REASON
Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
VOLUME OF PRODUCT IN COMMERCE 
278 units.
DISTRIBUTION 
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: Devices - CLASS III

_______________________________
PRODUCT
Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHNO10S. Recall # Z-0696-05.
CODE
Lots 11014, 12134 and 01105.
RECALLING FIRM/MANUFACTURER
Tri-State Hospital Supply Corp., Howell, MI, by letter dated March 8, 2005. Firm initiated recall is ongoing.
REASON
Some of the needles in these sets are ¾ inches in length instead of the labeled 1 inch.
VOLUME OF PRODUCT IN COMMERCE 
1,350 sets.
DISTRIBUTION 
AL, KY, MI, MS, MO, NC, and SC.

_______________________________
PRODUCT
Version 12 software program written for the Bio- Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. Recall # Z-0702-05.
CODE
Version 12.
FIRM/MANUFACTURER
Diasorin , Inc., Stillwater , MN , by letters on December 1, 2004 . Firm initiated recall is ongoing.
REASON
The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the Pro- Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.
VOLUME OF PRODUCT IN COMMERCE 
8 kits.
DISTRIBUTION 
CA, DC, FL, KY, and Canada .

_______________________________
PRODUCT
Version 7 software for wash program on Bio Tek Automated Microplate Washer Model Elx50 which performs the washing steps for various programmed mictotiter plate assays. Recall # Z-0703-05.
CODE
Version 7.
RECALLING FIRM/MANUFACTURER
Diasorin , Inc., Stillwater , MN , by telephone on May 20, 2004 . Firm initiated recall is ongoing.
REASON
When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model Elx50, the software did not automatically clear old versions of the wash program when new ones were added.
VOLUME OF PRODUCT IN COMMERCE 
9 kits.
DISTRIBUTION 
CA, FL, NH, PA, SD, TX, and WA.

______________________________
PRODUCT
DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Recall # Z-0704-05.
CODE
Lot # 04164.
RECALLING FIRM
Diasorin, Inc., Stillwater , MN , by letters on May 25, 2004 . 
Recalling Firm:
Manufacturer:
Diagnostic Systems Laboratories, Inc., Webster, TX. Firm initiated recall is ongoing.
REASON
Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.
VOLUME OF PRODUCT IN COMMERCE 
70 kits.
DISTRIBUTION 
MA and Internationally.

_______________________________
PRODUCT
DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. Recall # Z-0705-05.
CODE
Lot # 113300B.
RECALLING FIRM/MANUFACTURER
Diasorin , Inc., Stillwater , MN , by letter on June 30, 2004 . Firm initiated recall is ongoing.
REASON
An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.
VOLUME OF PRODUCT IN COMMERCE 
181 kits.
DISTRIBUTION 
Nationwide and Internationally.

________________________
PRODUCT
DiaSorin Analyte Specific Reagent. Recall # Z-0706-05.
CODE
Lot # 926603-08.
RECALLING FIRM/MANUFACTURER
Diasorin , Inc., Stillwater , MN , by letter on June 30, 2004 . Firm initiated recall is ongoing.
REASON
Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.
VOLUME OF PRODUCT IN COMMERCE 
6 (PRODUCT /ALB-IGGFITC-QTY 1; C3-IGGFITC-1; IGA-IGGFITC-2; IGG-IGGFITC-1; KAP-IGGFITC-1)
DISTRIBUTION 
WA, MA, and Korea .

_______________________________
PRODUCT
Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. Recall # Z-0708-05.
CODE
Lot #144444SA, Expiration Date: 01/2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trek Diagnostic Systems, Cleveland, OH, by telephone and fax on 3/4/2005 and a recall letter dated 3/4/2005.
Manufacturer: Trek Diagnostic Systems, Inc., Sun Prairie, WI. Firm initiated recall is ongoing.
REASON
Blood culture bottles with an error in the bar code on the labels, were shipped.
VOLUME OF PRODUCT IN COMMERCE 
193 cases (9,650).
DISTRIBUTION 
Nationwide.

_______________________________
PRODUCT
MEDPOR® Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non- Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 *. Recall # Z-0712-05.
CODE
Lot A004A02.
RECALLING FIRM/MANUFACTURER
Porex Surgical, Inc., Newnan , GA , by email, telephone and letter on March 7, 2005 and March 8, 2005 . Firm initiated recall is ongoing.
REASON
The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres.
VOLUME OF PRODUCT IN COMMERCE 
30 units.
DISTRIBUTION 
AZ, IL, NJ and Korea .

END OF ENFORCEMENT REPORT FOR APRIL 27, 2005

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