Home / Recalls / Medical Devices
New Wave Endo-Surgical, Corp. recalls M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Recalled May 17, 2023 · FDA recall Z-1570-2023 · New Wave Endo-Surgical
Hazard
The plastic housing on the device may fracture · FDA Class II
Units
295 units
Sold at
US Nationwide distribution in the states of FL, MA, and GA.
Description
The plastic housing on the device may fracture
Product
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Manufacturer(s)
New Wave Endo-Surgical, Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →