Recall Z-1602-2023 ยท GCJ Laparoscope, General & Plastic Surgery
Surgical Innovations Ltd
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
| Date | May 17, 2023 (initiated Mar 28, 2023) |
| Status | Open, Classified |
| Reason | Optical Trocars sterility assurance can not be guaranteed |
| Root cause | Other |
| Action | On March 29, 2023, Surgical Innovations issued a "Urgent Field Safety Notice" to affected consignees via E-Mail. An update to the communication was sent on 4/17/2023 to affected consignees via E-Mail. In addition to informing consignees about the recall, Surgical Innovations ask consignees to take the following action: 1. Distributor should confirm receipt of this Field Safety Notice 2. Identify the devices held in stock at the distributor and quarantine affected batches awaiting further instruction. 3. Issue this Field Safety Notice to all end users (Hospital) that the distributor has supp |
| Quantity | 3405 units |
| Distribution | US: MA OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210495 | Port Access System Surgical Innovations Limited, Jun 18, 2021 |