FDAClass IIFebruary 16, 2022

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with recall

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

Why was MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with recalled?

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

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?

1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544

Product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Recalling firm
Avanos Medical, Inc.
Quantity
692 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Recall date
February 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls