FDA recall Z-2465-2020

Product

Isolation Droplet Bundle Kit

Reason for recall

Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.

Distribution

Domestic distribution only to: MO and LA.

Key facts

Status

Terminated

Initiation date

2020-05-19

Report date

2020-07-08

Termination date

2020-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2465-2020