Recall Z-2246-2021— Richard Wolf GmbH

Name: FDA recall Z-2246-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-25

Class II · Terminated

Class II FDA medical device recall by Richard Wolf GmbH, initiated 2021-06-25, terminated 2024-01-05. It names one FDA 510(k) clearance: K062720. Product: CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323. Reason: Product labeled as Cutting Electrode may contain BIVAP electrode..

Recalling firm: Richard Wolf GmbH
Classification: Class II
Status: Terminated
Initiated: 2021-06-25
Terminated: 2024-01-05
Firm location: Knittlingen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODESRichard Wolf Medical Instruments Corp.·cleared 2007-03-22

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

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

Reason for recall

Product labeled as Cutting Electrode may contain BIVAP electrode.

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