Recall Z-2418-2023 ยท GCJ Laparoscope, General & Plastic Surgery
Carefusion 2200 Inc
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
| Date | Sep 30, 2024 (initiated Jul 13, 2023) |
| Status | Open, Classified |
| Reason | Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process. |
| Root cause | Nonconforming Material/Component |
| Action | BD issued an URGENT: Medical Device Product Recall notice to its consignees on 13 July 2023 via FedEx 2-day and email. The notice explained the problem with the device, the risk to the patient, and requested the following actions: Medical facilities: - Discontinue the use of the affected device and destroy it - Share the notice with all users within your facility network - If the product was purchased through a distributor, contact the distributor directly for further instructions. Distributors were directed to Identify all customers within your distribution network that purchased any aff |
| Quantity | 0 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930667 | REUSABLE LAPAROSCOPIC INSTRUMENTS Snowden-Pencer, May 16, 1994 |