Device product
BLAST Bandage, sterile.
Z-2538-2018
Product summary
- Event
- Event 80157
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,097 units
- Official record key
device-enforcement:Z-2538-2018
Official wording
Reason: Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.
Code information: Lot 0617
Distribution pattern: Domestic distribution to AL, AP, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MO, MS, NC, ND, NM, NY, OH, PA, SC, TX, VA, WI. International distribution to Austria, Canada, France, Kenya, Latvia, Netherlands, New Zealand, Poland, Singapore, South Africa, Switzerland, Turkey, United Kingdom.
Derived failure modes
-
Unknown
Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.