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U.S. Department of Health and Human Services

Class 2 Device Recall Esmark Elastic Bandage, 4" x 3 yards

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  Class 2 Device Recall Esmark Elastic Bandage, 4" x 3 yards see related information
Date Initiated by Firm November 18, 2008
Date Posted January 16, 2009
Recall Status1 Terminated 3 on November 04, 2009
Recall Number Z-0616-2009
Recall Event ID 50198
Product Classification Bandage, elastic - Product Code FQM
Product Esmark Elastic Bandage, 4" x 3 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Park, IL 60085-6787.

The device is used to promote blood flow from the extremities by compressing the superficial vessels.
Code Information Catalog number 23580-043: Work order numbers 310652, 316815, 324060 and 327413.
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-473-1500
Manufacturer Reason
for Recall		 The natural rubber latex bandages were mislabeled as latex free.
FDA Determined
Cause 2		 Labeling Change Control
Action A recall letter dated 11/17/08 was issued to the Directors of Materials Management and sent via DHL 2-day service on 11/18/08. Accounts were advised that the elastic bandages containing latex were mislabeled as latex free. Customers were requested to return their inventories of the affected product to Cardinal Health for credit or replacement by calling the Presource Customer Sales Operations Group at 800-766-0706 for return instructions. Customers were also requested to complete the enclosed Cardinal Customer Acknowledgement form by indicating the amount of affected product being returned and fax it to 847-689-9101. Please direct questions to Quality Systems, Professional Services at 800-292-9332.
Quantity in Commerce 9,521 units (of all devices)
Distribution Worldwide Distribution including USA, Guam and Korea.
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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