—#69114

Product

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 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; 32331100, 32531400, 32944300, 33078800, 33208400, 33342100, 60006805, 60045252, 60088425, 60118920, 60174047, 60215672, 60269221, 60321524, 60385874, 60540737, 60564969, 60607918 and 60629972.

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 #69114. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.