Recall Z-1528-06 ยท MHW Dressing, Compression
International Medsurg Connection, Inc.
Allegiance Esmark 4' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-044A
| Date | Sep 29, 2006 (initiated Aug 16, 2006) |
| Status | Terminated |
| Reason | The bandages labeled as sterile had not been sterilized prior to distribution. |
| Root cause | Other |
| Action | International Medsurg Connection recalled the Esmark Bandages from Cardinal Health by telephone call on 8/16/06 and follow-up letter dated 8/24/06. The account was informed that some of the product may not have been sterilized even though it was labeled as sterile, and was requested to cease distribution of the affected lots, return the product to IMC and notify their customers to the retail level. Cardinal Health in turn notified their customers by letter dated 8/24/06, addressed to the Director of Materials Management, informing them of the possible non-sterilization of the product. Hos |
| Quantity | 88 cases |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.