Class 2 Device Recall 3M Ioban

• Date Initiated by Firm: April 07, 2003
• Date Posted: May 16, 2003
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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