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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits

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 Class 2 Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kitssee related information
Date Initiated by FirmJanuary 31, 2008
Date PostedApril 09, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall NumberZ-1453-2008
Recall Event ID 46792
Product Classification Wound Drainage Device Infection Control Kits - Product Code GCY
ProductZimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-702-10; 400 ml INF. CNTRL. Kit W/ 1/8" Drain Spec., 3.2mm, 10Fr., PVC, 107cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
Code Information Lot Numbers; 60004885, 60018681, 60030745, 60045264, 60056512, 60090134, 60101563, 60124258, 60152076, 60189147, 60192877, 60198414, 60217797, 60236478, 60255679, 60281660, 60314033, 60377257, 60402970, 60406391, 60419371, 60444465, 60463238, 60479892, 60511109, 60554807, 60575194, 60586769, 60607929 and 60621372.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
330-365-3793
Manufacturer Reason
for Recall		Leakage: The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.
FDA Determined
Cause 2		Process control
ActionConsignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.
Quantity in Commerce34,354 (Recalls Z-1448/1458-2008)
DistributionWorldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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