Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/ 3/16" Drain Spec., 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2550-703-10.
FDA Recall Z-1494-2008 · Posted 2008-09-19
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeGCY
Date Initiated2008-01-29
Date Terminated2009-11-12
Reason for Recall
The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.
Firm Action
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
Distribution Pattern
Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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