FDA Device recall Z-0382-2023
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
- FDA Device
- Class II
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112 by Carefusion 2200, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0382-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-02 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion 2200 |
| Distribution | US |
Product
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
Reason
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.
Identifiers
| code_info | UDI/DI 10885403040795, ALL LOTS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0382-2023%22
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