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Terminated

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 Recall Z-0777-06 · Posted 2006-04-19

Recalling FirmMedline Industries, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2006-03-30
Date Terminated2006-05-09
Product Quantity21 cases

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Texas

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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