Recall Z-0398-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Carefusion 2200 Inc
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008
| Date | Dec 3, 2022 (initiated Nov 2, 2022) |
| Status | Open, Classified |
| Reason | XXX |
| 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 de |
| Quantity | 4 units |
| Distribution | Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213386 | Titan Manufacturing Bipolar Forceps Titan Manufacturing, Inc., Oct 25, 2021 |