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Terminated

Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays per case

FDA Recall Z-0645-03 · Posted 2003-03-12

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeMCY
Date Initiated2003-02-12
Date Terminated2003-08-12
Product Quantity207 cases

Reason for Recall

Some of the kits labeled as latex free contain latex gloves which are properly labeled.

Firm Action

Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Official Source

View FDA Recall →

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

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