Recall Z-1466-2024 ยท GCJ Laparoscope, General & Plastic Surgery
Covidien, LP
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
| Date | Apr 3, 2024 (initiated Feb 28, 2024) |
| Status | Open, Classified |
| Reason | The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| Root cause | Labeling design |
| Action | On February 28, 2024, the firm notified customers of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Inform all surgeons and clinicians who handle the preparation and/ or placement of a Mesh Device that utilize the balloon and blunt tip trocar devices. 2. Prior to using any Mesh device in conjunction with the following Trocars: Covidien Auto Suture" Structural Balloon Trocar and Auto Suture" Blunt Tip Trocar, please carefully review and adhere to the mesh manufacturer s Instructions for Use (IFU) on proper insertion techniques. 3. Please complete an |
| Quantity | 315,716 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924011 | ORIGIN BLUNT TIP SURGICAL TROCAR Origin Medsystems, Inc., Jul 9, 1993 |