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Terminated

Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case

FDA Recall Z-0644-03 · Posted 2003-03-12

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeGBX
Date Initiated2003-02-12
Date Terminated2003-08-12
Product Quantity753 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K822510SUCTION CATHETER W/STERILE WATERMedine Dynacor · 1982-10-13

Official Source

View FDA Recall →

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

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