M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Reported: May 17, 2023 Initiated: July 8, 2020 #Z-1570-2023
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
Details
- Recalling Firm
- New Wave Endo-Surgical, Corp.
- Units Affected
- 295 units
- Distribution
- US Nationwide distribution in the states of FL, MA, and GA.
- Location
- Coconut Creek, FL
Frequently Asked Questions
What product was recalled? ▼
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall. Recalled by New Wave Endo-Surgical, Corp.. Units affected: 295 units.
Why was this product recalled? ▼
The plastic housing on the device may fracture
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Moderate. Recall number: Z-1570-2023.
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