Z-0838-03

3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ

Name: Z-0838-03 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
Creator: 3m Health Care
Published: 2003-04-07
License: https://open.fda.gov/license/

3M Company / initiated 2003-04-07 / Terminated

FDA source

3m Health Care began a recall of 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ on 2003-04-07. The reason FDA records is "The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0838-03
Status: Terminated
Initiated: 2003-04-07
Posted: 2003-05-16
Terminated: 2004-07-02
Recalling firm: 3M Company
Product: 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
Product code: KKX Drape, Surgical, Antimicrobial
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 root 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.
Product codes and lots: 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.

Product code KKX

K801550Class II3M Germicidal Surgical Incise Drape3M Company / cleared 1981-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)