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
- Recall date
- July 8, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1570-2023
- FDA classification
- Class II
- Brand / firm
- New Wave Endo-Surgical, Corp.
- Sold / distributed
- US Nationwide distribution in the states of FL, MA, and GA.
Why it was recalled
The plastic housing on the device may fracture
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
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