Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107
FDA device recall Z-1489-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.
- Action taken
- Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GCY
- Distribution
- Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapor
- Date initiated
- 2008-01-29
- Date posted
- 2008-09-19
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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