| Class 2 Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits | |
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
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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
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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 |
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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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