Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
- Recall Initiated
- January 20, 2022
- Posted
- September 29, 2022
- Recall Number
- Z-1852-2022
- Quantity
- 19
Reason for Recall
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Distribution
US: MA
Lot / Code Info
Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029
Root 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