Recall Z-1852-2022
Surgical Innovations Ltd · initiated January 20, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Codes / lots: Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029
Reason for recall
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
FDA-determined cause: Process control
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
Details
- Recall number
- Z-1852-2022
- Initiated
- January 20, 2022
- Posted by FDA
- September 29, 2022
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 19
- Distribution
- US: MA
- Recalling firm
- Surgical Innovations Ltd, Leeds
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1853-2022 Class II | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic…Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | 01/20/2022Open, Classified |