FDA recall Z-2538-2018

Product

BLAST Bandage, sterile.

Reason for recall

Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.

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, United Kingdom.

Key facts

Status

Terminated

Initiation date

2018-04-17

Report date

2018-08-01

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anderson, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2538-2018