The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0371-2020·Announced 2019-11-20

Avanos Medical Recalls CORFLO PEG Kits Due to Connector Defect

Avanos Medical is recalling CORFLO PEG Kits because the connector piece does not pass over the guidewire. The recall affects 104 cases distributed to six US states and Great Britain.

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: The recall is classified as FDA Class II. The defect prevents the connector from passing over the guidewire, posing a risk of harm during a medical procedure, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Avanos Medical, Inc. is recalling CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kits, labeled as CORFLO PEG Kit with ENFit Connector. The devices may be branded as Halyard Health. The recall involves 104 cases, totaling 208 units, with catalog numbers 50-4016E1 and 50-4020E1.

The recall was initiated because the connector piece to the PEG tube does not pass over the guidewire. This defect could prevent proper installation of the device. The affected lots are 0203137961, 0203172166, and 0203069043.

The products were distributed to Connecticut, Indiana, Maryland, New Jersey, Pennsylvania, and Virginia, as well as to Great Britain. Healthcare providers and patients should stop using the affected devices and contact Avanos Medical for instructions on replacement or return.

The recalled product

Product
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Gastrostomy Tubes
Hazard

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)

  • Catalog Number: 50-4016E1 (Lot Numbers:0203137961
  • 0203172166)
  • Catalog Number: 50-4020E1 (Lot Number: 0203069043)

Distribution

Distributed in 6 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 →

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