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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-1456-2008
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; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio;
Code Information Lot Numbers: 32237200, 32285400, 32326900, 32349300, 32380000, 32413600, 32444100, 32471900, 32503500, 32538000, 32552400, 32580700, 32928800, 32980300, 33043400, 33121100, 33166500, 33222900, 33300500, 33328900, 33387100, 33432000, 60057314, 60075861, 60094646, 60113078, 60117514, 60134951, 60156026, 60176003, 60203020, 60227311, 60249134, 60278438, 60356862, 60389058, 60617386 and 60621549.
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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