FDA recall Z-2246-2021

Richard Wolf GmbH · Class II · device

Product

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

Reason for recall

Product labeled as Cutting Electrode may contain BIVAP electrode.

Distribution

US Nationwide Distribution in the states of CA, CO, IN, MA, NH

Key facts

Status
Terminated
Initiation date
2021-06-25
Report date
2021-08-18
Termination date
2024-01-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Knittlingen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2246-2021