AbClose
MEDEON BIODESIGN, INC. · Model M12 Rev.V24 · UDI-DI 04719872920328
Description
The AbClose Port Site Closure Device includes the following components: • One (1) Suture Passer • One (1) Suture Guide The AbClose - Port Site Closure Device is a sterile, single-use device, which includes one Suture Guide and one Suture Passer. The Suture Guide has two channels to direct the Suture Passer with suture strand into the Suture Catcher. The Suture Catcher grasps the end of the suture strand. By withdrawing the Suture Guide from the abdominal cavity after the sutures are deployed, the device automatically creates a loop for closure. At the end, any standard knot tying technique may be performed by the physician to close the incision.
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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