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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-1458-2008
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: 47-2550-050-10; 400 ml evacuators and 450 ml collection bags, evaluator tubing and universal Y connectors, adapters for silicone drains, contains 10, non-sterile, latex-free, Zimmer, Dover, Ohio.
Code Information Lot Numbers: 32256400, 32380100, 33143800, 33234000, 33348300, 33423400, 60047748, 60066632, 60084083, 60116363, 60212361, 60220450, 60266724, 60329424, 60398330, 60456738, 60475725, 60575171, 60581678 and 60612083.
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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