—#69111

Product

Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-703-10; 400 ml INF. CNTRL. Kit W/ 3/16" Drain Spec., 4.8mm, 15Fr., PVC, 107cm, 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 product code: GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: 60045265, 60101564, 60154830, 60196965, 60333503, 60412506, 60453016 and 60633939.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

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

Timeline

Recall initiated: 2008-01-31
Posted by FDA: 2008-04-09
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.