RecallDepth

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

Company
Medline Industries, Inc.
Recall Initiated
March 30, 2006
Posted
April 19, 2006
Terminated
May 9, 2006
Recall Number
Z-0777-06
Quantity
21 cases
Firm Location
Waukegan, IL

Reason for Recall

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

Distribution

Texas

Lot / Code Info

Reorder number DYNJP1047, lot 5149116

Root Cause

Other

Action Taken

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.

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