Recall Z-0392-2023— Carefusion 2200 Inc
Class II · Ongoing
Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2022-11-02. It names one FDA 510(k) clearance: K213386. Product: Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000. 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..
- Recalling firm
- Carefusion 2200 Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-02
- Firm location
- Vernon Hills, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.