Agency classClass IIOur severity:High FDA (Devices)·Z-0566-2022·Announced 2022-02-16

Avanos MIC Percutaneous Gastrostomy Kit Recalled for Bolster Sizing Defect

Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy PEG Kit because the external retention bolster may be larger than the tube, creating a risk of improper fit and potential device failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving a structural sizing defect in a critical feeding and medication delivery component. This qualifies as a risk-of-harm product where no injuries have been reported, meeting the High severity criterion.

Plain-English summary

Avanos Medical, Inc. is recalling the MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors (20 Fr-PULL model). The recalled kits were distributed worldwide, including across the United States, Canada, and Chile.

The external retention bolster contained in these kits may be a larger diameter than the tube. This sizing defect could result in improper fit between the bolster and tube, potentially leading to device failure or disconnection during use. The defect affects 692 units with the following lot codes: Code 8160-20 Lot 30135103 and Code 8640-20 Lot 30132544.

Patients or healthcare providers using affected PEG kits should contact their healthcare provider or Avanos Medical for instructions on whether replacement or inspection is needed. Do not discontinue use of the device without medical guidance, as this could interrupt essential nutrition or medication delivery.

The recalled product

Product: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Manufacturer: Avanos Medical, Inc.
Category: Medical Device — Feeding tube / Gastrostomy
Hazard: improper-fit
disconnection-risk
Affected units: 692

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Avanos Medical, Inc.

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Same hazard · improper fit