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Terminated

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

FDA Recall Z-2246-2021 · Posted None

Recalling FirmRichard Wolf GmbH
Recall StatusTerminated
Product CodeFJL
Date Initiated2021-06-25
Date Terminated2024-01-05
Product Quantity20 boxes

Reason for Recall

Product labeled as Cutting Electrode may contain BIVAP electrode.

Firm Action

The firm notified its importer 06/25/2021 and subsequently initiated the recall by letter (titled URGENT SAFETY INFORMATION) to its consignees on 06/29/2021. The letter explained the issue and the hazard, and requested consignees and user facilities scrap the affected device.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062720S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODESRichard Wolf Medical Instruments Corp. · 2007-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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