Medical device recalls Moderate risk

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

Get recall alerts

Free email alert whenever New Wave Endo-Surgical, Corp. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: New Wave Endo-Surgical, Corp.