Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use i
FDA device recall Z-1852-2022 · posted 2022-09-29 · Open, Classified
Recall details
- Recalling firm
- Surgical Innovations Ltd
- Reason for recall
- Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
- Action taken
- 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 email: quality@surginno.co.uk
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 19
- Distribution
- US: MA
- Date initiated
- 2022-01-20
- Date posted
- 2022-09-29
- Location
- Leeds, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| YelloPort Elite Port Access System (K190592) | Surgical Innovations Limited | 2019-04-29 |