Allegiance Esmark 4' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient

FDA device recall Z-1528-06 · posted 2006-09-29 · Terminated

Recall details

Recalling firm

International Medsurg Connection, Inc.

Reason for recall

The bandages labeled as sterile had not been sterilized prior to distribution.

Action taken

International Medsurg Connection recalled the Esmark Bandages from Cardinal Health by telephone call on 8/16/06 and follow-up letter dated 8/24/06. The account was informed that some of the product may not have been sterilized even though it was labeled as sterile, and was requested to cease distribution of the affected lots, return the product to IMC and notify their customers to the retail level. Cardinal Health in turn notified their customers by letter dated 8/24/06, addressed to the Director of Materials Management, informing them of the possible non-sterilization of the product. Hospitals were requested to contact Cardinal Customer Service at 800-964-5227 to arrange for product return and credit or replacement of all product. All other customers were directed to call 1-888-444-5440 for product return and replacement. All questions were directed to Cardinal Quality Systems at 800-292-9332 or Mr. Manny Gupta at International Medsurg Connection at 847-619-9929.

Root cause

Other

Status

Terminated

Product code

MHW

Quantity affected

88 cases

Distribution

Nationwide

Date initiated

2006-08-16

Date posted

2006-09-29

Date terminated

2007-01-24

Location

Schaumburg, IL