Device product
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.
Z-1649-2014
Product summary
- Event
- Event 67858
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,860 bandages
- Official record key
device-enforcement:Z-1649-2014
Official wording
Reason: This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Code information: Product Number: DYNJ05116A . Lot Number: 13LA1009.
Distribution pattern: Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Derived failure modes
-
Unknown
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.