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Terminated

Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486

FDA Recall Z-0114-04 · Posted 2003-11-13

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeKKX
Date Initiated2003-10-07
Date Terminated2003-11-12
Product Quantity44 cases

Reason for Recall

The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.

Firm Action

Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned product.

Root Cause

Other

Distribution Pattern

Ohio, Iowa, Illinois, Wisconsin and Indiana

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEMedline Industries, Inc. · 1996-11-26

Official Source

View FDA Recall →

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

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