Recall Z-1649-2014 ยท FQM Bandage, Elastic
Medline Industries Inc
Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.
| Date | May 21, 2014 (initiated Mar 20, 2014) |
| Status | Terminated |
| Reason | This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile. |
| Root cause | Employee error |
| Action | Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have |
| Quantity | 2,860 bandages |
| Distribution | Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.