CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Carefusion V recalled by Carefusion 2200
Carefusion 2200 is recalling Carefusion V, distributed nationwide in the US. The recall was initiated on 2 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0381-2023
- FDA event ID
- 90967
- Recalling firm
- Carefusion 2200, Vernon Hills, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Nov 2022
- FDA classified
- 3 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 2 Nov 2022 | Recall initiated by company | |
| 3 Dec 2022 | Classified by FDA | +31 days |
| 14 Dec 2022 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111
Where it was distributed
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
Questions about this recall
Is Carefusion V recalled?
Yes. Carefusion 2200 recalled Carefusion V on 2 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0381-2023.
Why was it recalled?
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.
Which lots are affected?
UDI/DI 10885403040788, ALL LOTS
Where was it sold?
Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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