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Terminated

Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China, Manufactured for Medline Industries, Mundelein IL 60060

FDA Recall Z-2198-2011 · Posted 2011-05-13

Recalling FirmJiangsu Wujin Hualian Health Dressing Co., Ltd.
Recall StatusTerminated
Product CodeKGX
Date Initiated2011-02-22
Date Terminated2012-04-23
Product Quantity1,092 cases

Reason for Recall

The sterility of the product has the potential to be compromised due to weak sealing of the bandages.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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