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Recall Observatory FDA recall evidence

Device product

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

Z-1570-2023

July 08, 2020

Class II

Product summary

Firm
New Wave Endo-Surgical, Corp.
Event
Event 92005
Status
Terminated
Classification
Class II
Quantity
295 units
Official record key
device-enforcement:Z-1570-2023

Official wording

Reason: The plastic housing on the device may fracture

Code information: UDI/DI: 00850009417022, Lot code C2020

Distribution pattern: US Nationwide distribution in the states of FL, MA, and GA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The plastic housing on the device may fracture