—#45369

Product

Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Reorder number DYNJP1047, lot 5149116

Why it was recalled

The product may not be sterile. The pouches were damaged during sterilization.

Root cause (FDA determination)

Other

Action the firm took

The direct account hospital was visited by a Medline sales representative on 3/30/06, and the affected product was retrieved and returned to Medline.

Recalling firm

Firm: Medline Industries, Inc.
Address: 1170 S Northpoint Blvd, Waukegan, Illinois 60085-6757

Distribution

Distribution pattern: Texas

Timeline

Recall initiated: 2006-03-30
Posted by FDA: 2006-04-19
Terminated: 2006-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45369. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.