The Recall Desk
SevereFDA (Devices)·Z-0370-2020·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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or structural defects are assigned a score of 4 (Severe).

Plain-English summary

Avanos Medical, Inc. is recalling 104 cases (208 units) of CORFLO Percutaneous Endoscopic Gastrostomy (PEG) Kits. The devices, which may be branded as Halyard Health, are labeled as CORFLO PEG Kit and contain 2 units per case. The recall is classified as Class II by the FDA.

The recall is being conducted because the connector piece to the PEG tube does not pass over the guidewire. This defect could prevent the proper installation of the device. The affected products are identified by Catalog Number 30-4020 (Lot Numbers: 0203145253, 0203081127) and Catalog Number 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065).

The affected units were distributed to Connecticut, Indiana, Maryland, New Jersey, Pennsylvania, and Virginia, as well as internationally to Great Britain. Healthcare facilities and consumers should check their inventory for these specific catalog and lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions.

The recalled product

Product
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 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 (7)

  • Catalog Number: 30-4020 (Lot Numbers:0203145253
  • 0203081127)
  • Catalog Number: 30-4320 (Lot Numbers: 0002994173
  • 0202974008
  • 0202907370
  • 0203201718
  • 0203241065)

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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