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U.S. Department of Health and Human Services

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Enforcement Report for June 20, 2007

Enforcement Report

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.

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June 20, 2007
07-25

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS I

___________________________________
PRODUCT
Product is JTM brand Italian Sausage Hoagie, net weight 10 oz, Recall # F-319-7
CODE
The ''true code'' as established by JTM is: 6270CD. The Case code is: 06270 (The ''CD'' is not incorporated in the case code). The code ''06270'' represents the year and Julian date of production. Wal-Mart adds a stick-on label to individual sandwiches which has the code: 6270CD/80, and the ''Sell By Date: 11/20/06''.
RECALLING FIRM/MANUFACTURER
Recalling Firm:  JTM Provisions Co, Harrison, OH, by press release dated November 11, 2006 and by e-mail on November 14, 2006.
Manufacturer:  Classic Delight Inc, St Marys, OH.  Firm initiated recall is ongoing.
REASON
The Florida Department of Agriculture and Consumer Services found the product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,073 cases/12/10 oz. sandwiches per case
DISTRIBUTION
AR, FL, IN, KY, NE, NV, NY, OH, PA, VA
_________________________________
PRODUCT
a) Energy Club Healthy California Mix, packaged in a) 4 ounce (UPC# 01952) and
    b) 7 ounce (UPC# 21952) pillow bags with header labels, Recall# F-320-7;
b) Raisin Nut Mix, packaged in a) 3 ounce (UPC#00964) and b) 7.25 ounce (UPC#01964)
    pillow bags with header labels, Recall # F-321-7
CODE
a) On Package 6 digit expiration date stamped XX XX XX (Month-Day-Year)
    Note: Expiration date is 1 year from production. a) 4oz (1952) = 10/5&24/07;
    11/9,10,20&21/07; 12/4&18/07; 1/8&25/08; 2/14&19/08; 3/2,12,14&28/08
    b) 7oz (21952) = 11/9/07; 12/15,19&26/07; 2/7&8/08; 3/6&16/08;
b) On Package 6 digit expiration date stamped XX XX XX (Month-Day-Year)
    Note: Expiration date is 1 year from production date. a) 3oz (964) = 10/18/07;
    11/1, 22&30/07; 12/15,21&26/07; 1/15/08; 2/2,20,25&27/08; 3/5,15&29/08
    b) 7.25oz (1964) = 12/24/07; 11/7, 22&29/07; 12/11&26/07; 1/15,16&23/08; 2/5&21/08;
    3/5, 14&21/08
RECALLING FIRM/MANUFACTURER
Energy Club Inc., Pacoima, CA, by telephone and e-mail on March 29, 2007 and by press release and letter on April 5, 2007. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
a) 4oz = 22,044 bags; 7oz = 1,440 bags;
b) 3oz = 12,984 bags; 7.25oz = 23,220 bags
DISTRIBUTION
Nationwide and Caribbean
___________________________________
PRODUCT
a) Hot Wing Sauces, in glass and plastic bottles and tubs, under the following labels and sizes:
    1) Scorned Woman Wicked Wing Sauce, 18 oz., UPC 081119 909132;
    2) Jim Beam Hot Wing Sauce, 5 oz., UPC 020023 035988;
    3) Jim Beam Hot Wing Sauce, 13 oz., UPC 020023 035629;
    4) Jim Beam Gourmet Foods Hot Wing Sauce, 1 gal.; 
    5) IU Hoosiers Varsity Wing Sauce, 12 oz., UPC 072736 030026;
    6) Virginia Tech Hot Wing Sauce, 12 oz., UPC 072736 020027;
    Recall # F-322-7;
b) Budweiser Basting Sauce, packaged in 14 oz., 71 oz., 1 gal. and 5 gal. plastic
    bottles and pails, Recall # F-323-7;
c) Budweiser Barbecue Sauce, 19 oz., 77 oz, 1 gal, 5 gal. bottles and tubs, Recall # F-324-7
CODE
a) 1) Date codes 5/04/07 - 1/18/08,
    2) Date codes 4/17/07 - 11/7/07,
    3) Date codes 1/26/07 - 12/19/07,
    4) Date codes 10/25/07,
    5) Date codes 1/10/07 - 7/26/07,
    6) Date codes 1/10/07 - 7/26/07;
b) All date codes through 12/19/07;
c) All date codes through 6/11/08
RECALLING FIRM/MANUFACTURER
Vita Specialty Foods, Inc., Martinsburg, WV, by telephone, letter and press release on February 12, 2007. Firm initiated recall is ongoing.
REASON
Barbecue sauces were processed with a sub-ingredient containing milk, which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
a) 296,500 bottles;
b) 104,000 bottles;
c) 405,000 bottles
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS II

____________________________________
PRODUCT
Glacier Valley brand Spring Water, Item #41554, and Le Alpi brand Spring Water, Item #41555, packed in 3 oz. plastic cups with foil lids. 120 cups per case, Recall # F-164-7
CODE
Glacier Valley brand Spring Water and Le Alpi brand Spring Water are identified with the Lot Code: E0077 A1 printed on outer case, and the Expiration Date: 01/06/09. Additional lot codes of Glacier Valley brand Spring Water identified with the Lot #E-0567 B2 printed on the outer case and the following Expiration Dates are also included in the recall: 09/15/08, 12/20/08, 12/29/08, 01/13/09, 02/24/09, 03/02/09, 03/04/09, 03/05/09, and 03/07/09
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Country Pure Foods Inc., Akron, OH, by letters on February 23, 2007, March 15, 2007 and March 26, 2007.
Manufacturer:  Country Pure Foods, Inc., Ellington, CT.  Firm initiated recall is ongoing.
REASON
Laboratory analysis indicated bromate levels in excess of Federal limit of 10 ppb.
VOLUME OF PRODUCT IN COMMERCE
10,968 cases x 120 cups per case
DISTRIBUTION
AZ, FL, NJ, NY, IL, WI, CT, OH, VA and GA
___________________________________
PRODUCT
Galliker Healthy Chekd Calcium Enriched Fat Free Milk sold in plastic half gallon containers, Recall  # F-318-7
CODE
Code date May 14, 2007
RECALLING FIRM/MANUFACTURER
Galliker Dairy Co, Inc., Johnstown, PA, by press, visit, and telephone beginning on May 3, 2007.  Firm initiated recall is complete.
REASON
The product contained excessive levels of Vitamin A.
VOLUME OF PRODUCT IN COMMERCE
2,966 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Roland Cerignola Olives, Dr. wt. 5 lbs. (2.27 Kg.), Product of Italy. The product is packed in a cellophane bag weighing 5 lbs. and sold 2/5 lbs. bags per case. Item # 71706, UPC 41224 71706, Recall # F-325-7
CODE
Code shown on product as Letter "G" followed by 3 or 4 digits
RECALLING FIRM/MANUFACTURER
Recalling Firm:  American Roland Food Corp., New York, NY, by press release on March 27, 2007, and by letters dated March 29, 2007 and April 16, 2007.
Manufacturer:  Charlie Brown di Rutigliano & Figli S.r.l., Binetto, Italy.  Firm initiated recall is ongoing.
REASON
The product was manufactured under conditions whereby it may have been rendered hazardous to health. It may not have been adequately processed to prevent the growth of harmful bacteria such as those which cause botulism.
VOLUME OF PRODUCT IN COMMERCE
400 cases
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
Armour Thyroid (thyroid tablets, USP), 3 grain (180 mg), each tablet contains levothyroxine (T4) 144 mcg and liothyronine (T3) 27 mcg, 100-tablet bottles, Rx only, NDC 0456-0462-01, Recall # D-813-2007
CODE
Lots: 010711, exp. 6/08; 030714, exp. 7/08; 030723, exp. 8/08
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Forest Pharmaceuticals Inc., Earth City, MO, by letter dated May 7, 2007.
Manufacturer:  Forest Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Printing error on bottle label incorrectly states 144 mcg Levothyroxine (T4) per tablet. Label should state 114 mcg Levothyroxine (T4) per tablet.
VOLUME OF PRODUCT IN COMMERCE
10,781/100-tablet bottles
DISTRIBUTION
Nationwide and Belgium
___________________________________
PRODUCT
a) Cooldent-Coolmint Ice Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes, labeled ingredients
    include Sodium Monofluorophosphate 0.5% and Diglycol. UPC barcodes: 8-40929-03901-5 &
    8-40929-03903-9, Recall # D-814-2007;
b) Cooldent-Spearmint Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes, labeled
    ingredients include Sodium Monofluorophosphate 0.5% and Diglycol.
    UPC barcodes: 8-40929-03904-6 & 8-40929-03906-0, Recall # D-815-2007;
c) Cooldent-Fluoride Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes, labeled
    ingredients include Sodium Monofluorophosphate 0.5% and Diglycol.
    UPC barcodes: 8-40929-03907-7 & 8-40929-03908-4, Recall # D-816-2007
CODE
a) Item Numbers: S3901(toothpaste with toothbrush) & S3903 (toothpaste only);
b) Item Numbers: S3904 (toothhpaste only) & S3906 (toothpaste with toothbrush);
c) Item Numbers: S3907 (toothpaste only) & S3908 (toothpaste with toothbrush)
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Selective Imports Corp., Vernon, CA, by telephone on May 31, 2007 and by letter on June 4, 2007.
Manufacturer:  Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland).  Firm Initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
399,120 tubes
DISTRIBUTION
AZ, CA, FL, GA, IL, UT, & TX

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I

___________________________________
PRODUCT
ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent, Recall # Z-0855-2007
CODE
Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, by letter on March 8, 2007, press release on May 25, 2007 and by follow-up letter on May 29, 2007.
Manufacturer: Fisher Diagnostics, A Company of Fisher Scientific LLC, Middletown VA.  Firm initiated recall is ongoing.
REASON
False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL
VOLUME OF PRODUCT IN COMMERCE
9,438 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system, Recall # Z-0739-2007
CODE
Part model numbers: 9896 010 00614 Accession Number 9521074 and 9511022; and 9896 010 00615 Accession Number 9521074 and 9511022
RECALLING FIRM/MANUFACTURER
Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on March 20, 2007.  Firm initiated recall is ongoing.
REASON
The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard 21 CFR 1020.31 (d)(2)(iii)
VOLUME OF PRODUCT IN COMMERCE
6 collimators
DISTRIBUTION
IA, LA, ND, PA, TX, and DC
___________________________________
PRODUCT
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (System hardware consists of a processing unit and a monitor), Patient Monitor, Recall # Z-0891-2007
CODE
All serial numbers of Software Version 4.1
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on March 13, 2007. Firm initiated recall is ongoing.
REASON
Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot.
VOLUME OF PRODUCT IN COMMERCE
5,190 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
IMS Patient Scale used on Sunrise Medical’s Hoyer Presence and Stature Patient Lifts (Cradle), Models:  HOY-4PT-WSC and HOY- STATUREWSC, Recall # Z-0921-2007
CODE
All serial numbers for Model No.  HOY-4PT-WSC and HOY-STATUREWSC
RECALLING FIRM/MANUFACTURER
Integrated Measurement Systems, Inc., Elk Grove Village, IL, by telephone on January 30, 2007.  Firm initiated recall is ongoing.
REASON
Patient Scale may become detached, which can cause a patient to fall and result in injury.
VOLUME OF PRODUCT IN COMMERCE
149 units
DISTRIBUTION
WI
___________________________________
PRODUCT
EP Healing abutment. Product Code-ITHA52. A pre-manufactured prosthetic component directly connected to an endosseous dental implant, Recall # Z-0922-2007
CODE
Lot number:  560988
RECALLING FIRM/MANUFACTURER
Biomet 3i, Palm Beach Gardens, FL, by e-mail on October 16, 2006, by telephone and letter on October 19, 2006. Firm initiated recall is ongoing.
REASON
Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
VOLUME OF PRODUCT IN COMMERCE
597 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126, Recall # Z-0933-2007
CODE
All devices with sterile lot numbers beginning with S, CR, or any C4 lot numbers starting with CP 05274 or higher.
RECALLING FIRM/MANUFACTURER
Recalling Firm:  St Jude Medical CRMD, Sylmar, CA, by letter on March 20, 2007.
Manufacturer:  Oscor, Inc., Palm Harbor, FL. Firm initiated recall is ongoing.
REASON
Device Separation. Product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
VOLUME OF PRODUCT IN COMMERCE
14,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Recall # Z-0934-2007
CODE
V036775
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Medtronic Neurological, Minneapolis, MN, by telephone and field representative visit in April 2007.
Manufacturer:  Medtronic Puerto Rico Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
REASON
The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).
VOLUME OF PRODUCT IN COMMERCE
31 kits
DISTRIBUTION
CA, CO, IL, IN, MD, NC, OH, PA, and WV
___________________________________
PRODUCT
HUMIDIFLOW Respiratory Gas Humidifier; Part Number/Model # HMK-RM, Recall # Z-0935-2007
CODE
Lot # 072849001 Serial #‘s: 1009202067, 1027061A, 100920067, 1109061, 102020061B, 102020061
RECALLING FIRM/MANUFACTURER
Porous Media Corporation, Saint Paul, MN, by letter dated April 26, 2007.  Firm initiated recall is ongoing.
REASON
The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient).
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide, Canada, Mexico, and Japan

___________________________________
PRODUCT
Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt, Recall # Z-0936-2007
CODE
Serial numbers with active patients: 79000004, 79000055, 79000064, 79000073, 79000106, 79000157, 79000181, 79000205, 79000208, 79000217, 79000226, 79000238, 79000244, 79000259, 79000274, 79000277, 79000286, 79000289, 79000298, 79000328, 79000346, 79000358, 79000364, 79000367, 79000373, 79000376, 79000379, 79000388, 79000403, 79000409, 79000445, 79000454, 79000457, 79000466, 79000487, 79000490, 79000493, 79000508, 79000511, 79000529, 79000532, 79000547, 79000556, 79000562, 79000574, 79000577, 79000595, 79000598, 79000601, 79000604, 79000616, 79000631, 79000634, 79000637, 79000640, 79000652, 79000661, 79000670, 79000686, 79000685, 79000694, 79000697, 79000715, 79000727, 79000730, 79000739, 79000754, 79000760, 79000769, 79000790, 79000796, 79000799, 79000802, 79000811, 79000823, 79000829, 79000832, 79000835, 79000838, 79000841, 79000844, 79000847, 79000853, 79000856, 79000886, 79000889, 79000901, 79000904, 79000925, 79000931, 79000934, 79000937, 79000943, 79000958, 79000973, 79000979, 79000982, 79000994, 79001003, 79001018, 79001021, 79001024, 79001027, 79001030, 79001033, 79001036, 79001042, 79001048, 79001054, 79001060, 79001066, 79001078, 79001081, 79001093, 79001099, 79001102, 79001111, 79001117, 79001147, 79001150, 79001153, 79001156, 79001162, 79001198, 79001201, 79001207, 79001216, 79001219, 79001228, 79001237, 79001243, 79001255, 79001273, 79001276, 79001288, 79001300, 79001318, 79001339, 79001354, 79001357, 79001363, 79001369, 79001372, 79001375, 79001378,79001384, 79001387, 79001399, 79001402, 79001405, 79001408, 79001417, 79001423, 79001429, 79001441, 79001444, 79001456, 79001459, 79001462, 79001468, 79001486, 79001492, 79001498, 79001501, 79001504, 79001522, 79001525, 79001528, 79001534, 79001537, 79001540, 79001558, 79001564, 79001570, 79001573, 79001582, 79001585, 79001588, 79001594, 79001597, 79001603, 79001630 79001639, 79001642, 79001648, 79001654, 79001657, 79001660, 79001666, 79001672, 79001675, 79001681, 79001690, 79001693, 79001699, 79001714, 79001717, 79001732, 79001738, 79001741, 79001744, 79001750, 79001753, 79001756, 79001759, 79001762, 79001765, 79001771, 79001777, 79001780, 79001786, 79001795, 79001798, 79001801, 79001804, 79001810, 79001822, 79001834, 79001837, 79001840, 79001846, 79001849, 79001852, 79001867, 79001879, 79001882, 79001906, 79001912, 79001918, 79001924, 79001939, 79001942, 79001945, 79001954, 79001957, 79001963, 79001969, 79001984, 79001996, 79002002, 79002005, 79002011, 79002017, 79002026, 79002041, 79002044, 79002047, 79002053, 79002056, 79002059, 79002068, 79002071, 79002074, 79002089, 79002110, 79002116, 79002119, 79002122, 79002128, 79002140, 79002152, 79002155, 79002164, 79002170, 79002176, 79002179, 79002182, 79002185, 79002191, 79002194, 79002200, 79002206, 79002215, 79002218, 79002221, 79002224, 79002227, 79002233, 79002236, 79002248, 79002251, 79002263, 79002275, 79002278, 79002287, 79002290, 79002293, 79002305, 79002308, 79002320, 79002329, 79002332, 79002338, 79002347, 79002359, 79002368, 79002377, 79002392, 79002404, 79002413, 79002416, 79002422, 79002425, 79002428, 79002440, 79002446, 79002449, 79002452, 79002455, 79002458, 79002479, 79002482, 79002494, 79002497, 79002509, 79002512, 79002521, 79002524, 79002530, 79002533, 79002539, 79002554, 79002560, 79002563, 79002566, 79002578, 79002587, 79002593, 79002602, 79002605, 79002608, 79002617, 79002620, 79002623, 79002629, 79002635, 79002644, 79002647, 79002650, 79002659, 79002665, 79002671, 79002674, 79002677, 79002698, 79002701, 79002710, 79002728, 79002740, 79002749, 79002761, 79002764, 79002767, 79002770, 79002776, 79002779, 79002782, 79002785, 79002788, 79002794, 79002800, 79002806, 79002818, 79002827, 79002833, 79002842, 79002848, 79002860, 79002863, 79002866, 79002869, 79002875, 79002878, 79002881, 79002884, 79002896, 79002899, 79002902, 79002911, 79002917, 79002932, 79002938, 79002941, 79002950, 79002962, 79002965, 79002968, 79002971, 79002974, 79002977, 79002980, 79002983, 79002989, 79002992, 79003007, 79003010, 79003016, 79003019, 79003028, 79003031, 79003034, 79003037, 79003049, 79003052, 79003055, 79003058, 79003067, 79003070, 79003079, 79003082, 79003088, 79003097, 79003103, 79003118, 79003121, 79003130, 79003133, 79003136, 79003142, 79003151, 79003157, 79003166, 79003172, 79003175, 79003178, 79003190, 79003196, 79003199, 79003205, 79003211, 79003223, 79003229, 79003235, 79003244, 79003262, 79003265, 79003274, 79003277, 79003295, 79003316, 79003325, 79003328, 79003331, 79003346, 79003349, 79003373, 79003382, 79003400, 79003415, 79003445, 79003454, 79003457, 79003460, 79003463, 79003469, 79003472, 79003478, 79003493, 79003508, 79003511, 79003520, 79003526, 79003529, 79003538, 79003544, 79003550, 79003553, 79003556, 79003568, 79003583, 79003589, 79003592, 79003598, 79003601, 79003604, 79003607, 79003613, 79003616, 79003628, 79003631, 79003634, 79003637, 79003640, 79003646, 79003649, 79003652, 79003658, 79003661, 79003664, 79003670, 79003673, 79003697, 79003700, 79003703, 79003706, 79003715, 79003718, 79003721, 79003727, 79003730, 79003748, 79003757, 79003760, 79003763, 79003766, 79003769, 79003778, 79003784, 79003793, 79003796, 79003808, 79003823, 79003835, 79003838, 79003841, 79003844, 79003847, 79003850, 79003856, 79003862, 79003868, 79003871, 79003877, 79003889, 79003916, 79003919, 79003922, 79003949, 79003958, 79003961, 79003967, 79003976, 79003985, 79003988, 79004000, 79004003, 79004012, 79004021, 79004027, 79004042, 79004066, 79004078, 79004087, 79004096, 79004108, 79004117, 79004120, 79004126, 79004129, 79004135, 79004141, 79004144, 79004153, 79004162, 79004165, 79004210, and 79004216.
Foreign serial numbers with active patients: 79000118, 79000724, 79000736, 79000343, 79000664, 79001075, 79001213, 79000310, 79000394, 79000139, 79000187, 79001231, 79001600, 79000256, 79000370, 79000463, 79000514, 79000592, 79000703, 79000745, 79000766, 79000808, 79001090, 79001171, 79001177, 79001315, 79001336, 79001345, 79001351, 79001390, 79001615, 79001825, 79001870, 79001900, 79001960, 79001966, 79002008, 79002062, 79002149, 79002203, 79002230, 79002272, 79002398, 79002464, 79002488, 79002491, 79002500, 79002545, 79002551, 79002584, 79002590, 79002611, 79002614, 79002680, 79002812, 79002953, 79003013, 79003022, 79003025, 79003094, 79003100, 79003124, 79003127, 79003139, 79003232, 79003247, 79003319, and 79003355.
Serial numbers still under the firm's control: 79000058, 79000190, 79000196, 79000211, 79000214, 79000241, 79000247, 79000253, 79000283, 79000325, 79000334, 79000340, 79000352, 79000391, 79000427, 79000439, 79000448, 79000475, 79000541, 79000544, 79000589, 79000643, 79000667, 79000712, 79000721, 79000772, 79000781, 79000784, 79000793, 79000814, 79000826, 79000850, 79000859, 79000862, 79000865, 79000874, 79000880, 79000895, 79000910, 79000913, 79000952, 79000961, 79000964, 79000985, 79000988, 79001012, 79001063, 79001072, 79001105, 79001120, 79001123, 79001138, 79001180, 79001225, 79001240, 79001252, 79001282, 79001291, 79001297, 79001303, 79001309, 79001312, 79001321, 79001324, 79001333, 79001360, 79001396, 79001420, 79001471, 79001489, 79001507, 79001546, 79001579, 79001591, 79001612, 79001621, 79001702, 79001723, 79001729, 79001792, 79001819, 79001828, 79001855, 79001861, 79001888, 79001903, 79001909, 79001927, 79001933, 79001951, 79001975, 79001981, 79001990, 79002032, 79002035, 79002038, 79002050, 79002065, 79002092, 79002095, 79002101, 79002125, 79002131, 79002134, 79002143, 79002146, 79002158, 79002173, 79002209, 79002245, 79002257, 79002269, 79002281, 79002302, 79002311, 79002314, 79002326, 79002350, 79002356, 79002395, 79002401, 79002410, 79002419, 79002434, 79002461, 79002470, 79002476, 79002569, 79002572, 79002575, 79002581, 79002596, 79002599, 79002632, 79002662, 79002683, 79002686, 79002692, 79002704, 79002713, 79002734, 79002743, 79002746, 79002773, 79002791, 79002803, 79002845, 79002851, 79002857, 79002893, 79002908, 79002923, 79002929, 79002935, 79002956, 79003019, 79003046, 79003085, 79003112, 79003148, 79003154, 79003160, 79003163, 79003169, 79003184, 79003187, 79003193, 79003214, 79003217, 79003226, 79003238, 79003241, 79003250, 79003253, 79003298, 79003301, 79003313, 79003322, 79003334, 79003340, 79003352, 79003379, 79003475, 79003481, 79003490, 79003496, 79003514, 79003541, 79003547, 79003571, 79003574, 79003577, 79003586, 79003643, 79003709, 79003724, 79003742, 79003751, 79003787, 79003790, 79003805, 79003814, 79003817, 79003832, 79003859, 79003865, 79003874, 79003892, 79003895, 79003904, 79003913, 79003925, 79003937, 79003940, 79003943, 79003952, 79003994, 79004006, 79004009, 79004030, 79004033, 79004036, 79004039, 79004045, 79004048, 79004063, 79004069, 79004072, 79004090, 79004093, 79004099, 79004102, 79004105, 79004111, 79004114, 79004132, 79004138, 79004147, 79004156, 79004159, 79004183, 79004186, 79004201, 79004204, 79004207, and 79004240.
Foreign serial numbers still under the firm's control: 79000361, 79000817, 79001132, 79001915, 79000499, 79000868, 79000898, 79001009, 79001414, 79001432, 79002284, 79003004, 79001258, 79001264, 79001279, 79001234, 79001249, 79000187, 79000559, 79001381, 79000265, 79000292, 79000349, 79000406, 79000424, 79000469, 79000520, 79000565, 79000625, 79000649, 79000673, 79000691, 79000877, 79001039, 79001087, 79001435, 79001474, 79001495, 79001513, 79001567, 79001606, 79001609, 79001774, 79001885, 79001930, 79001948, 79002020, 79002299, 79002365, 79002443, 79002503, 79002506, 79002668, 79002689, 79002755, 79002986, 32687900, 79003292, 79003310, 79003337, 79003358, 79003364, 79003403, 79003406, 79003409, and 79003412
RECALLING FIRM/MANUFACTURER
Zoll Lifecor Corporation, Pittsburgh, PA, by letter on May 3, 2007. Firm initiated recall is ongoing.
REASON
The electrodes do not properly release conductive gel
VOLUME OF PRODUCT IN COMMERCE
944 belts
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD)
    size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use,
    Non-Sterile; Recall # Z-0937-2007;
b) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD)
    size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use,
    Non-Sterile; Recall # Z-0938-2007;
c) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD)
    size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443
    (5 pack); Single Use, Non-Sterile; Recall # Z-0939-2007;
d) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD)
    size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735
    (5 pack); Single Use, Non-Sterile; Recall # Z-0940-2007;
e) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD)
    size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736
    5 pack); Single Use, Non-Sterile; Recall # Z-0941-2007;
f) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD)
    size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379
    (5 pack); Single Use, Non-Sterile; Recall # Z-0942-2007;
g) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)
   size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile;
    Recall # Z-0943-2007;
h) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)
    size 8mm (24 Fr), length 4cm; product code/end item #000845; Single Use,
    Non-Sterile; Recall # Z-0944-2007;
i) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)
   size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use,
   Non-Sterile; Recall # Z-0945-2007;
j) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)
   size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack);
   Single Use, Non-Sterile; Recall # Z-0946-2007;
k) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)
    size 15mm (45 Fr), length 4cm; product code/end item #000848 and #000858 (5 pack);
    Single Use, Non-Sterile; Recall # Z-0947-2007;
l) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)
    size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack);
    Single Use, Non-Sterile; Recall # Z-0948-2007;
m) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD)
    size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack);
    Single Use, Non-Sterile; Recall # Z-0949-2007
CODE
Lots manufactured between May 03, 2006 and December 14, 2006. Corresponding lot numbers between 0605031 and 0612141. Lot code breakdown    as follows: For lot #0605031: 06 = year (2006); 05 = month (May); 03 = Day of Month (3rd); 1 = Manufacturing Shift Code (1st shift)
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Conmed Endoscopic Technologies, Inc., Billerica, MA, by letters on April 16, 2007 and April 17, 2007.
Manufacturer:  Servicios Ensamble Internacionales, Ciudad Juarez, Mexico. Firm initiated recall is ongoing.
REASON
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
VOLUME OF PRODUCT IN COMMERCE
12,350 packaged units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Biomet 3i, disposable twist drills, Model number DT2715, Recall # Z-0959-2007
CODE
Lot Numbers:  635699—2012-1 and 652460—2012-3
RECALLING FIRM/MANUFACTURER
Biomet 3i, Palm Beach Gardens, FL, by telephone, email and letter beginning on May 14, 2007. Firm initiated recall is ongoing.
REASON
The depth indicator laser line markings on the drills are too faint for clinicians to read during use.
VOLUME OF PRODUCT IN COMMERCE
147 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,
    (PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following
    components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
    Recall # Z-0960-2007;
b) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,
    (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following
    components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
    Recall # Z-0961-2007;
c) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,
    (PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following
    components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,  
    Recall # Z-0962-2007;
d) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,
    (PSD 21-U-V), 21mm, US Surgical Staplers. Each package contains the following
    components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
    Recall # Z-0963-2007;
e) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,
    ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following
    components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
    Recall # Z-0964-2007;
f) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,
    (PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following  
    components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
    Recall # Z-0965-2007
CODE
a) 5713042-221741, 5713423-227242, 5717696-316474, 5717892-318414, 5718084-321564,
    5718811-335330, 5718931-337921, 5719156-342542, 5717892-408336, 5718084-408339,
    5719536-348390, 5721731-391016, 5721732-391017, 5721988-395784, 5722089-397032,
    5725033-478976, 5725482-487062, 5725665-491224, 5725782-495452, 5726120-498547,
    5727333-525321, 5721988-540345, 5727334-525322.
    EXPANDED LOT/SERIAL #'s: 5728409-544891, 5729325-562207, 5727334-560764;
b) 5719288-345247, 5720137-358402, 5720206-359198, 5721249-375999, 5721733-391018,
    5723148-421902, 5722090-397033, 5722420-406658, 5723509-433792, 5723703-439270,
    5723810-441317, 5724696-467329, 5725034-478977, 5725483-487063, 5725792-495462,
    5726121-498548, 5726493-506246, 5721249-540340, 5726841-516569.
    EXPANDED LOT/SERIAL #'s: 5726841-560767, 5726842-516570, 5727664-532483,
    5727970-538817, 5727971-538818, 5728410-544892, 5728683-549953, 5729326-562208,
    5729700-569547, 5729701-569548;
c) 5713060-221868, 5713061-221869, 5714567-250264, 5712862-215844, 5715407-268139,
    5717353-310944-001, 5717354-310947-002, 5717355-310948-003, 5717356-310950-004,
    5717357-310951-005, 5717358-310953-006, 5717359-310954-007, 5717360-310955-008,
    5717361-310956-009, 5717362-310957-010, 5717403-311742-017, 5717404-311743-018,
    5717405-311744-019 , 5717406-311745-020, 5717407-311746-021, 5717408-311747-022,
    5717409-311748-023, 5717410-311749-024, 5717411-311750-025, 5717412-311751-026,
    5717413-311752-027, 5717414-311753-028, 5717415-311754-029, 5717416-311755-030,
    5717397-311734-011, 5717398-311737-012, 5717399-311738-013, 5717400-311739-014,
    5717401-311740-015, 5717402-311741-016, 5717417-311756-031, 5717418-311757-032,
    5717578-314896-033, 5717579-314897-034, 5716064-280283, 5716065-280284,
    5717580-314898-035, 5717581-314999-036, 5717582-314901-037, 5717583-314902-038,
    5717584-314903-039, 5717585-314904-040, 5717586-314905-041, 5717587-314906-042,
    5717588-314907-043, 5717589-314908-044, 5713061-396028, 5713061-396088,
    5714567-395788, 5714567-396037, 5714567-396041, 5714567-396047, 5714567-396085,
    5714567-396831, 5714567-408289, 5716453-285027.
    EXPANDED LOT/SERIAL #'s: 5716453-285027, 5716453-577195;
d) 5713057-221865, 5713421-227240, 5727945-538783, 5728518-547271.
    EXPANDED SERIAL/LOT #'s: 5728518-560761 and 5729324-562206;
e) 5713058-221866, 5713424-227243, 5718660-334090, 5719772-353003, 5721250-376000;
f) 5713059-221867, 5713425-227244, 5717618-314939-001, 5717619-314940-002,
    5717620-314941-003, 5717621-314942-004, 5717622-314943-005, 5717623-314944-006,
    5717624-314945-007, 5717625-314946-008, 5717626-314947-009, 5717627-314948-010,
    5713059-301281, 5713425-332644, 5713425-332648, 5713425-395826.
    EXPANDED SERIAL/LOT#: 5716063-280282
RECALLING FIRM/MANUFACTURER
Synovis Surgical Inovation, Saint Paul, MN, by letters on March 16, 2007, April 23, 2007 and May 5, 2007.  Firm initiated recall is ongoing.
REASON
Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
VOLUME OF PRODUCT IN COMMERCE
3,902 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JUNE 20, 2007

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