Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
FDA Recall Z-1852-2022 · Posted 2022-09-29
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Recalling FirmSurgical Innovations Ltd
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2022-01-20
Product Quantity19
Reason for Recall
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Firm Action
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]
Root Cause
Process control
Distribution Pattern
US: MA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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