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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Ioban

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  Class 2 Device Recall 3M Ioban see related information
Date Initiated by Firm April 07, 2003
Date Posted May 16, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-0838-03
Recall Event ID 25979
510(K)Number K801550  
Product Classification Drape, Surgical - Product Code KKX
Product 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
Code Information 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and February 28, 2003, were recalled.
Recalling Firm/
3m Health Care
3m Center
Saint Paul MN 55144-1001
Manufacturer Reason
for Recall
The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
FDA Determined
Cause 2
Action 3M sent Cardinal Health a letter dated April 7, 2003 to provide to their customers. The letter instructed the customers to remove Ioban 2 drapes contained in Cardinal Health packs and use a separately supplied equivalent drape.
Quantity in Commerce 3679 drapes
Distribution Procedure packs containing the drapes were shipped nationwide in United States.
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 = 3M COMPANY