Recall Z-1868-2018— Richard Wolf GmbH

Name: FDA recall Z-1868-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-11

Class II · Terminated

Class II FDA medical device recall by Richard Wolf GmbH, initiated 2018-03-11, terminated 2022-03-09. It names one FDA 510(k) clearance: K000180. Product: RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.. Reason: Tube ends may be mixed up..

Recalling firm: Richard Wolf GmbH
Classification: Class II
Status: Terminated
Initiated: 2018-03-11
Terminated: 2022-03-09
Firm location: Knittlingen, Germany

510(k) clearances named in this recall

1 on FDA's record

K000180 — TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOPRichard Wolf Medical Instruments Corp.·cleared 2001-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Tube ends may be mixed up.

Data sourced from openFDA. This site is unofficial and independent of the FDA.