Class 2 Device Recall Medline Blue O.R. Towel

• Date Initiated by Firm: October 07, 2003
• Date Posted: November 13, 2003
• Recall Status: Terminated on November 12, 2003
• Recall Number: Z-0114-04
• Recall Event ID: 27507
• 510(K)Number: K962205
• Product Classification: Drape, Surgical - Product Code KKX
• Product: Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
• Code Information: Reorder #MDT2168204, lot 03IA0532
• Recalling Firm/ Manufacturer: Medline Industries Inc; 1 Medline Pl; Mundelein IL 60060-4485
• For Additional Information Contact: Joe Dunn; 800-950-0128
• Manufacturer Reason for Recall: The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 44 cases
• Distribution: Ohio, Iowa, Illinois, Wisconsin and Indiana
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KKX