—#196324

Product

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K213386
Affected lot / code info: UDI/DI 10885403040801, ALL LOTS

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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: productcomplaints@bd.com" 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

Recalling firm

Firm: Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern: Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand

Timeline

Recall initiated: 2022-11-02
Posted by FDA: 2022-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.