The Recall Desk
HighFDA (Devices)·Z-2161-2017·Announced 2017-05-31

CORPAK CORFLO PEG Adaptor Repair Kit Recalled for Connector Breakage

CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break unexpectedly when exposed to stress.

What this means for you

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 involves a medical device with a structural defect that could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CORPAK MedSystems, Inc. is initiating a voluntary correction for CORFLO PEG Adaptor Repair Kits with ENFit Connectors, Size 12FR (4mm). The recall involves 2 cases (5 units per case) with Catalogue Number 50-6112.

The recall is being conducted because the barb connector (stem) of the adapter may break unexpectedly when exposed to stress. These PEG tubes are intended for the delivery of enteral nutrition, water, and medications into the stomach, with the adapter serving as the connection point between the tubing and the feeding set or syringe.

The affected products were distributed worldwide in the states of New Hampshire, Vermont, and California, as well as in the United Kingdom, Ireland, France, Austria, Norway, Sweden, and New Zealand. Consumers and healthcare providers should stop using the affected adapters and contact CORPAK MedSystems for further instructions.

The recalled product

Product
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syri
Manufacturer
CORPAK MedSystems, Inc.
Category
Medical Device — Enteral Feeding Devices
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 (1)

  • Catalogue Numbers: 50-6112

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 3 recalled by CORPAK MedSystems, 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 3 products in this recall →

Related recalls

Same manufacturer · CORPAK MedSystems, Inc.

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Same hazard · structural defect

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