—#69094

Product

Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" Soft Drain , 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-030-05.

FDA product code: CAC — Apparatus, Autotransfusion
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.

Why it was recalled

The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2008-01-29
Posted by FDA: 2008-09-19
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69094. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.