Device product
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.
Z-0295-2018
Product summary
- Event
- Event 78360
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,722 units total
- Official record key
device-enforcement:Z-0295-2018
Official wording
Reason: Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Code information: Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614
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.
Derived failure modes
-
Unknown
Product did not undergo correct sterilization procedures and may potentially be non-sterile.