Allegiance Esmark 4' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-044A
This recall has been terminated (originally issued September 29, 2006).
- Recall Initiated
- August 16, 2006
- Posted
- September 29, 2006
- Terminated
- January 24, 2007
- Recall Number
- Z-1528-06
- Quantity
- 88 cases
- Firm Location
- Schaumburg, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The bandages labeled as sterile had not been sterilized prior to distribution.
Distribution
Nationwide
Lot / Code Info
Catalog 24593-044A, lot 06-2071-1
Root Cause
Other
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.