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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-1450-2008
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 00-2550-003-10; 400 ml INF. Cntrl. Kit w/ 3/16" drain, 4.8 mm, 15Fr, PVC, 107 cm, soft, 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: 60006897, 60030744, 60051038, 60067688, 60075523, 60099441, 60113095, 60134967, 60152075, 60168775, 60184523, 60200854, 60227354, 60240752, 60275128, 60299770, 60329438, 60339077, 60367783, 60385889, 60402652, 60437089, 60493507, 60525201, 60554806, 60581694, 60617399 and 60629984.
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 for (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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