M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
FDA Recall Z-1570-2023 · Posted 2023-05-09
Recalling FirmNew Wave Endo-Surgical, Corp.
Recall StatusTerminated
Product CodeHCF
Date Initiated2020-07-08
Date Terminated2024-07-02
Product Quantity295 units
Reason for Recall
The plastic housing on the device may fracture
Firm Action
New Wave Endo issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION to its consignees by email on 07/08/2020. The notice explained the problem with the device and requested the consignee quarantine the device and respond using the recall acknowledgement form. The units were returned and replaced.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of FL, MA, and GA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.