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Terminated

Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-003-10; 400 ml INF. Cntrl. Kit w/ 3/16" drain, 4.8 mm, 15Fr, PVC, 107 cm, soft, 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.

FDA Recall Z-1450-2008 · Posted 2008-04-09

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeGCY
Date Initiated2008-01-31
Date Terminated2009-11-12
Product Quantity34,354 for (Recalls Z-1448/1458-2008)

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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