Recall Z-2198-2011 ยท KGX Tape And Bandage, Adhesive
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
| Date | May 13, 2011 (initiated Feb 22, 2011) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.