FDA recall Z-0184-2020

Andover Healthcare Inc. · Class II · device

Product

Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Reason for recall

Incomplete packaging seal of sterile product

Distribution

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

Key facts

Status
Terminated
Initiation date
2019-06-19
Report date
2019-10-30
Termination date
2020-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salisbury, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0184-2020