Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-002-10, 400 ml-INF. Cntrl. Kit
FDA device recall Z-1449-2008 · posted 2008-04-09 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCY
- Quantity affected
- 34,354 (Recalls Z-1448/1458-2008)
- Distribution
- Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
- Date initiated
- 2008-01-31
- Date posted
- 2008-04-09
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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