FDA recall Z-1868-2018

Richard Wolf GmbH · Class II · device

Product

RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

Reason for recall

Tube ends may be mixed up.

Distribution

Worldwide Distribution

Key facts

Status
Terminated
Initiation date
2018-03-11
Report date
2018-05-23
Termination date
2022-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Knittlingen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1868-2018