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Terminated

Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, soft, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio

FDA Recall Z-1457-2008 · Posted 2008-04-09

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeGCY
Date Initiated2008-01-31
Date Terminated2009-11-12
Product Quantity34,354 (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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