Recall Z-1852-2022 ยท GCJ Laparoscope, General & Plastic Surgery
Surgical Innovations Ltd
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
| Date | Sep 29, 2022 (initiated Jan 20, 2022) |
| Status | Open, Classified |
| Reason | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. |
| Root cause | Process control |
| Action | On 01/20/2022, Urgent Field Safety Notices were emailed to customers who were asked to do the following: 1) Quarantine affected devices and return to the recalling firm. 2) If the devices are no longer in stock, confirm whether devices were used clinically, and if so, whether the devices were sterilized in accordance with the Instructions for Use prior to use. 3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices were transferred. 4) Complete response form. The recalling firm provided the following emai |
| Quantity | 19 |
| Distribution | US: MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190592 | YelloPort Elite Port Access System Surgical Innovations Limited, Apr 29, 2019 |