FDAClass IIOctober 6, 2021

Pas-port Proximal Anastomosis System recall

PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

Why was Pas-port Proximal Anastomosis System recalled?

Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

All batch codes

Product
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Recalling firm
Aesculap Implant Systems LLC
Quantity
80 units
Distribution
US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Recall date
October 6, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls