Recall Z-2538-2018 ยท FQM Bandage, Elastic
Tactical Medical Solutions, Inc.
BLAST Bandage, sterile.
| Date | Apr 17, 2018 |
| Status | Terminated |
| Reason | Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized. |
| Root cause | Mixed-up of materials/components |
| Action | Customers were notified on 04/17/2018 via letter and email. Instructions included to review bandages in inventory for affected lot, contact Tactical Medical to arrange replacement, complete and return the Acknowledgement and Receipt Form. |
| Quantity | 1,097 units |
| Distribution | 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, Un |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.