Z-2538-2018 Class II Terminated
FDA device recall Z-2538-2018 was initiated by Tactical Medical Solutions, Inc. on April 17, 2018 and is designated Class II. Reason for recall: Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized. The recall status is terminated (terminated July 22, 2020). Affected quantity: 1,097 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- April 17, 2018
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,097 units
Product Description
BLAST Bandage, sterile.
Reason for Recall
Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.
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.
Code Information
Lot 0617