Recall Z-1570-2023 ยท HCF Instrument, Ligature Passing And Knot Tying
New Wave Endo-Surgical, Corp.
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
| Date | May 9, 2023 (initiated Jul 8, 2020) |
| Status | Terminated |
| Reason | The plastic housing on the device may fracture |
| Root cause | Under Investigation by firm |
| Action | New Wave Endo issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION to its consignees by email on 07/08/2020. The notice explained the problem with the device and requested the consignee quarantine the device and respond using the recall acknowledgement form. The units were returned and replaced. |
| Quantity | 295 units |
| Distribution | US Nationwide distribution in the states of FL, MA, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.