FDAClass IIOctober 5, 2022

Product/Part: YelloPort Elite 12x75 Pencil Point recall: Sterility Concern

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.

Why was Product/Part: YelloPort Elite 12x75 Pencil Point recalled?

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part/UDI-DI/Lot: ET1207503/05051986012438/735479, EA10NH/05051986012100/734029

Product
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Recalling firm
Surgical Innovations Ltd
Quantity
19
Distribution
US: MA
Recall date
October 5, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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