Z-0394-2023Class II

Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010

Name: Z-0394-2023 Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
Creator: Carefusion 2200 Inc
Published: 2022-11-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-11-02 / Open, Classified / root cause: labeling and UDI

FDA source

Carefusion 2200 Inc began a recall of Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010 on 2022-11-02. FDA classified it as Class II and gives the reason as "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 of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0394-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-02
Posted: 2022-12-03
Recalling firm: Medtronic, Inc.
Product: Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm issued an URGENT MEDICAL DEVICE RECALL NOTIFICATION to its consignees on 11/02/2022 by FedEx 2nd day mail. The notice explained the problem and the hazard and requested the following actions from medical professionals and hospitals: "Please Take the Following Actions: 1. Please check all inventory locations within your facility for the affected product listed in Appendix I of this recall notification. 2. The content that is missing from the BD IFU is provided in the attached V. Mueller" Bipolar Forceps IFU for your records; maintain the IFU content in the appropriate location as determined by your facility. 3. Share this recall notice with any users of the product, within your facilities, to ensure they are also aware of this recall notification. 4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the recall notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification." "Contact Information: If you require further assistance please contact: North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT; Email: [email protected]" Actions to be taken by the distributors: "Please Take the Following Actions: 1. Please check all inventory locations within your facility for the affected product listed in Appendix I of this recall notification. 2. The content that is missing from the BD IFU is provided in the attached V. Mueller" Bipolar Forceps IFU; attach this IFU to all affected product within your facility in order to ensure the IFU is supplied with the product to your customers. 3. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. 4. Complete and retur
Quantity in commerce: 1063 units
Distribution: Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
Product codes and lots: UDI/DI 10885403040962, ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0394-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0373-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0374-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0375-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0376-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0377-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0378-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0379-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0380-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0381-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0382-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0383-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0384-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0385-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0386-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0387-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0388-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0389-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0390-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0391-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0392-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0393-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0394-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0395-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0396-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0397-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0398-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0399-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0400-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0401-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0402-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0403-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0404-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0405-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0406-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0407-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0408-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0409-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0410-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0411-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0412-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0413-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0414-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0415-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0416-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03
Z-0417-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-03

Product code GEI

K213386Class IITitan Manufacturing Bipolar ForcepsTitan Manufacturing, Inc. / cleared 2021-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)