New Wave Endo-Surgical, Corp. Recall 92005
Description: M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
New Wave Endo-Surgical, Corp. Recall 92005 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1570-2023 |
| Event ID | 92005 |
| Event Description | M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, MA, and GA. |
| Quantity | 295 units |
| Recall Reason | The plastic housing on the device may fracture |
| Device Classification | 20230517 |
| Device Code Info | UDI/DI: 00850009417022, Lot code C2020 |
| Center Classification Date | 20230509 |
| Recall Initiation Date | 20200708 |
| Recalling Firm | New Wave Endo-Surgical, Corp. |
| Initial Notification | Telephone |
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