M-Close Kit
New Wave Endo-Surgery Inc. · Model 27-101 · UDI-DI 00850009417022
Description
The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, Nerve Block Needles are included for the administration of local anesthetic agents to provide regional and local anesthesia.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-29 | Aesculap Inc | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short |
| 2023-12-29 | Aesculap Inc | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short |
| 2020-07-08 | New Wave Endo-Surgical, Corp. | The plastic housing on the device may fracture |
| 2016-11-16 | Teleflex Medical | The devices wings may become partially detached from the EFx Shield during use. |
| 2016-03-24 | Teleflex Medical | Incorrect expiration date was printed on the product label. |
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