The Recall Desk
HighFDA (Devices)·Z-2163-2017·Announced 2017-05-31

CORPAK CORFLO PEG Kit Recall Due to Potential Connector Breakage

CORPAK MedSystems is voluntarily recalling CORFLO PEG Kits because the ENFit connector stem may break unexpectedly under 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 (connector breakage) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

CORPAK MedSystems, Inc. is initiating a voluntary correction for the CORFLO PEG Kit, Pull 16FR. The product is intended for the delivery of enteral nutrition, water, and medications into the stomach. The specific issue involves the PEG adapter, which serves as the connection point between the tubing and the feeding set or syringe.

The recall is being conducted because the ENFit connector (stem) of the adapter may break unexpectedly when exposed to stress. This defect could compromise the integrity of the feeding system.

The affected units are identified by Catalogue Number 50-6016. The recall involves 8 cases, with 2 units per case. These products were distributed worldwide in the United States 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 Kit, Pull 16FR. 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/syringe. The adapter is designed as a replaceabl
Manufacturer
CORPAK MedSystems, Inc.
Category
Medical Device — Enteral Feeding
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: 50-6016

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 failure

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