The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2162-2017·Announced 2017-05-31

CORPAK Recalls CORFLO PEG Adaptor Repair Kits Due to Breakage Risk

CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break under stress.

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 involves a medical device with a structural defect that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the High severity criteria.

Plain-English summary

CORPAK MedSystems, Inc. is initiating a voluntary correction for CORFLO PEG Adaptor Repair Kits with ENFit Connectors, Size 16FR. The recall involves 2 cases, containing 5 units per case, identified by Catalogue Number 50-6116.

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 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 Adaptor Repair Kit with ENFit Connectors, Size: 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.…
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: 50-6116

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 →

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