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Class 2 Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits |
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Date Initiated by Firm |
January 31, 2008 |
Date Posted |
April 09, 2008 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number |
Z-1448-2008 |
Recall Event ID |
46792 |
Product Classification |
Wound Drainage Device Infection Control Kits - Product Code GCY
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Product |
Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, 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: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact |
330-365-3793
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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.
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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
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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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