FDA recall Z-0581-2018

Avid Medical, Inc. · Class II · device

Product

AVID Medical QA Pack AV10654-10

Reason for recall

The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.

Distribution

Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.

Key facts

Status
Terminated
Initiation date
2017-07-03
Report date
2018-02-21
Termination date
2018-04-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2018