FDA recall Z-2051-2021

Baxter Healthcare Corporation · Class II · device

Product

EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.

Reason for recall

There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date

Distribution

United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.

Key facts

Status
Terminated
Initiation date
2021-06-15
Report date
2021-07-21
Termination date
2024-01-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2051-2021