Product Wiki · Recalls · U.S. FDA — Device Enforcement

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111 — recall Z-0381-2023

U.S. FDA — Device Enforcement · United States · 2022-11-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0381-2023
Date of alert
2022-11-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Carefusion 2200 Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10885403040788
Reported risk: BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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