FDA recall Z-2043-2018

Medical Action Industries Inc · Class II · device

Product

Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol.

Reason for recall

Product sterility potentially compromised.

Distribution

US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada

Key facts

Status
Terminated
Initiation date
2017-12-11
Report date
2018-06-06
Termination date
2020-09-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arden, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2043-2018