FDA recall Z-1570-2023
New Wave Endo-Surgical, Corp. · Class II · device
Product
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
US Nationwide distribution in the states of FL, MA, and GA.
Key facts
- Status
- Terminated
- Initiation date
- 2020-07-08
- Report date
- 2023-05-17
- Termination date
- 2024-07-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Coconut Creek, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1570-2023