Z-1570-2023 Class II Terminated
FDA device recall Z-1570-2023 was initiated by New Wave Endo-Surgical, Corp. on July 8, 2020 and is designated Class II. Reason for recall: The plastic housing on the device may fracture The recall status is terminated (terminated July 2, 2024). Affected quantity: 295 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2023
- Initiation Date
- July 8, 2020
- Termination Date
- July 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 295 units
Product Description
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Reason for Recall
The plastic housing on the device may fracture
Distribution Pattern
US Nationwide distribution in the states of FL, MA, and GA.
Code Information
UDI/DI: 00850009417022, Lot code C2020