Z-2198-2011

Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for...

Name: Z-2198-2011 Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for...
Creator: Jiangsu Wujin Hualian Health Dressing Co., Ltd.
Published: 2011-02-22
License: https://open.fda.gov/license/

Changzhou Hualian Health Dressing Co.,Ltd. / initiated 2011-02-22 / Terminated / root cause: manufacturing process

FDA source

Jiangsu Wujin Hualian Health Dressing Co., Ltd. began a recall of Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for Medline Industries, Mundelein IL 60060 on 2011-02-22. The reason FDA records is "The sterility of the product has the potential to be compromised due to weak sealing of the bandages". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2198-2011
Status: Terminated
Initiated: 2011-02-22
Posted: 2011-05-13
Terminated: 2012-04-23
Recalling firm: Changzhou Hualian Health Dressing Co.,Ltd.
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
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: The sterility of the product has the potential to be compromised due to weak sealing of the bandages.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot No. 100A229 and 100A212

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)