FDA Enforcement
Class II
Terminated
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.
Recall: Z-1649-2014
·
Reported May 28, 2014
Enforcement
- Recall Number
- Z-1649-2014
- Event ID
- 67858
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 28, 2014
- Initiation Date
- March 20, 2014
- Classification Date
- May 21, 2014
- Termination Date
- November 29, 2017
- Address
- 1 Medline Pl, N/A, Mundelein, IL, 60060-4485, United States
Description
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.
Reason
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Code Info
Product Number: DYNJ05116A . Lot Number: 13LA1009.
Distribution
Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Quantity
2,860 bandages