U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Drape, Surgical - Product Code KKX
원인
The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
조치
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.
3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and February 28, 2003, were recalled.