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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 Kits see related information
Date Initiated by Firm January 31, 2008
Date Posted April 09, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-1449-2008
Recall Event ID 46792
Product Classification Wound Drainage Device Infection Control Kits - Product Code GCY
Product Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-002-10, 400 ml-INF. Cntrl. Kit w/ 1/8" drain, 3.2 mm, 10Fr, PVC, 107 cm, 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: 33440800, 60006818, 60015773, 60025362, 60033385, 60047775, 60051617, 60060757, 60067687, 60072831, 60082265, 60090133, 60096160, 60102772, 60108662, 60118934, 60129193, 60139016, 60147493, 60154829, 60163266, 60171588, 60181669, 60190630, 60196964, 60203044, 60212869, 60223951, 60233568, 60245183, 60252225, 60266735, 60278451, 60288208, 60305457, 60317372, 60323772, 60331175, 60339076, 60346591, 60359577, 60372899, 60382573, 60391905, 60401085, 60409371, 60419370, 60430869, 60444464, 60463237, 60475741, 60488170, 60496915, 60511108, 60530243, 60546074, 60565010, 60578962, 60594499, 60607928, 60622522, 60626621 and 60640519.
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
Action Consignees 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 Commerce 34,354 (Recalls Z-1448/1458-2008)
Distribution Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
Total Product Life Cycle TPLC 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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