FDA Medical Device Recalls (openFDA)
Jiangsu Wujin Hualian Health Dressing Co., Ltd.: Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for Medline Industries, Mundelein IL 60060
- Recall number
- Z-2198-2011
- Recalling firm
- Jiangsu Wujin 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
- Status
- Terminated
- Initiated
- 2011-02-22
- Posted
- 2011-05-13
- Terminated
- 2012-04-23
- Reason
- The sterility of the product has the potential to be compromised due to weak sealing of the bandages.
- 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
- 1,092 cases
- Distribution
- Nationwide Distribution -- IL.
- Lot, serial or model codes
- Lot No. 100A229 and 100A212
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGX
- Firm FEI
- 3003807757
- Firm city
- Prov.
- Firm state
- Jiangsu
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28