• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Curad Flexible Fabric Bandage

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Curad Flexible Fabric Bandage
see related information
Date Posted May 13, 2011
Recall Status1 Terminated 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.
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-