FDAClass IIFebruary 16, 2022

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 recall

MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL

Why was MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 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 7160-20, Lots 30116959, 30132543, 30132545, and 30132546 2) Code 7640-20, Lots 30129345

Product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Recalling firm
Avanos Medical, Inc.
Quantity
2652 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