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U.S. Department of Health and Human Services

Class 2 Device Recall Allegiance Esmark 6" x 144" Bandage, Latex Free, Sterile

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  Class 2 Device Recall Allegiance Esmark 6" x 144" Bandage, Latex Free, Sterile see related information
Date Initiated by Firm August 16, 2006
Date Posted September 29, 2006
Recall Status1 Terminated 3 on January 24, 2007
Recall Number Z-1530-06
Recall Event ID 36169
Product Classification Bandage - Product Code MHW
Product Allegiance Esmark 6' 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 24593-064A
Code Information Catalog 24593-064A, lot 06-2071-1
Recalling Firm/
Manufacturer		 International Medsurg Connection, Inc.
935 N Plum Grove Rd Ste F
Schaumburg IL 60173-4770
For Additional Information Contact Mr. Manoj K. Gupta
847-619-9926
Manufacturer Reason
for Recall		 The bandages labeled as sterile had not been sterilized prior to distribution.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 128 cases
Distribution Nationwide
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.
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