Class 2 Device Recall CareFusion V. Mueller

• Date Initiated by Firm: November 02, 2022
• Date Posted: December 03, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0417-2023
• Recall Event ID: 90967
• 510(K)Number: K213386
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), REF F-52000
• Code Information: UDI/DI 10885403041297, ALL LOTS
• Recalling Firm/ Manufacturer: Carefusion 2200 Inc; 75 N Fairway Dr; Vernon Hills IL 60061-1845
• For Additional Information Contact: North American Regional Complaint Center; 844-823-5433
• Manufacturer 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.
• FDA Determined 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: 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
• Quantity in Commerce: 239 units
• Distribution: Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEI and Original Applicant = Titan Manufacturing, Inc.