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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Blue O.R. Towel

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  Class 2 Device Recall Medline Blue O.R. Towel see related information
Date Initiated by Firm October 07, 2003
Date Posted November 13, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MEDLINE INDUSTRIES, INC.
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