Recall Z-0412-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Carefusion 2200 Inc
CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
| Date | Dec 3, 2022 (initiated Nov 2, 2022) |
| Status | Open, Classified |
| 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. |
| 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 | 79 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 |