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New Wave Endo-Surgical, Corp. Recall 92005

Description: M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall

New Wave Endo-Surgical, Corp. Recall 92005 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1570-2023
Event ID92005
Event DescriptionM-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Product TypeDevices
DistributionUS Nationwide distribution in the states of FL, MA, and GA.
Quantity295 units
Recall ReasonThe plastic housing on the device may fracture
Device Classification20230517
Device Code InfoUDI/DI: 00850009417022, Lot code C2020
Center Classification Date20230509
Recall Initiation Date20200708
Recalling FirmNew Wave Endo-Surgical, Corp.
Initial Notification Telephone
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