Reported May 17, 2023 · Terminated
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
New Wave Endo-Surgical, Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: New Wave Endo-Surgical, Corp. · 6601 Lyons Rd Ste D8 · Coconut Creek, FL · 33073-3630
Is this the product you have?
- M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
- Lot codes and dates
- UDI/DI
00850009417022Lot code C2020
- UDI/DI
- Amount recalled
- 295 units
Where it was sold
Why it was recalled
The plastic housing on the device may fracture
This product could cause temporary or reversible health problems — stop using it.
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