Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Recall
- Recall Number
- Z-1853-2022
- Event Number
- 90801
- Firm
- Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom
- FEI Number
- 3002808173
- Product Code
- GCJ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- January 20, 2022
- Posted
- September 29, 2022
Description
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
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: [email protected]
US: MA
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