Z-0295-2018 Class II Terminated
FDA device recall Z-0295-2018 was initiated by Medline Industries Inc on July 18, 2017 and is designated Class II. Reason for recall: Product did not undergo correct sterilization procedures and may potentially be non-sterile. The recall status is terminated (terminated April 24, 2020). Affected quantity: 5,722 units total.
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2018
- Initiation Date
- July 18, 2017
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,722 units total
Product Description
Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
Reason for Recall
Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, WA and the countries of Canada, Saudi Arabia, and Netherlands.
Code Information
Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614