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U.S. Department of Health and Human Services

Class 2 Device Recall Curad Flexible Fabric Bandage

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  Class 2 Device Recall Curad Flexible Fabric Bandage see related information
Date Initiated by Firm February 22, 2011
Date Posted May 13, 2011
Recall Status1 Terminated 3 on April 23, 2012
Recall Number Z-2198-2011
Recall Event ID 58198
Product Classification Tape and bandage, adhesive - Product Code KGX
Product Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for Medline Industries, Mundelein IL 60060
Code Information Lot No. 100A229 and 100A212
Recalling Firm/
Manufacturer		 Jiangsu Wujin Hualian Health Dressing Co., Ltd.
55 Yuejin Rd.
Zouqu Town
Wujin City, Jiangsu Prov. China
Manufacturer Reason
for Recall		 The sterility of the product has the potential to be compromised due to weak sealing of the bandages.
FDA Determined
Cause 2		 Process control
Action Changzhou Hualian Health Dressing Co., Ltd notified sole consignee by e-mail and a Medical Device Recall letter, dated 3/18/2011. The letter identifies the affected product and the reason for the recall. The customer was to examine their inventory and quarantine the affected product. If the product had been further distributed, those customers were to be identified and notified of the recall. The enclosed response form was to be completed and returned to Medline Industries, Inc. Questions could be directed to Customer Service, Monday through Friday between 8:30 A.M. and 4:00 P.M.
Quantity in Commerce 1,092 cases
Distribution Nationwide Distribution -- IL.
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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