—#29984

Product

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

FDA product code: KKX — Drape, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K962205
Affected lot / code info: Reorder #MDT2168204, lot 03IA0532

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4485

Distribution

Distribution pattern: Ohio, Iowa, Illinois, Wisconsin and Indiana

Timeline

Recall initiated: 2003-10-07
Posted by FDA: 2003-11-13
Terminated: 2003-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.