Z-1649-2014 Class II Terminated
FDA device recall Z-1649-2014 was initiated by Medline Industries Inc on Mar 20, 2014 and is designated Class II. Reason for recall: This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile. The recall status is terminated (terminated Nov 29, 2017). Affected quantity: 2,860 bandages.
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2014
- Initiation Date
- Mar 20, 2014
- Termination Date
- Nov 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,860 bandages
Product 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 for Recall
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Distribution Pattern
Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Code Information
Product Number: DYNJ05116A . Lot Number: 13LA1009.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1649-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026