The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2293-2019·Announced 2019-08-28

DeRoyal Enteral Safe Feeding Tubes Recalled for Connector Detachment

DeRoyal Industries is recalling specific polyurethane feeding tubes because the connector may detach from the tube.

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, and the hazard involves a structural defect in a medical device that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

DeRoyal Industries Inc is recalling certain DeRoyal Enteral Safe Feeding Tubes due to a product concern where the connector has detached from the feeding tube. The recall affects four specific reference numbers: 54-2450R, 54-2465R, 54-2480R, and 54-3680R. The affected units are polyurethane feeding tubes of varying French sizes and lengths.

The recall involves 180 cases of 10 units each. The products were distributed nationwide in the United States, specifically in the states of North Dakota, Texas, Illinois, Ohio, New Mexico, Utah, New Brunswick, Kentucky, and Colorado. Specific lot numbers are associated with each reference number, including 142844 and 143130 for REF 54-2450R, 142843 for REF 54-2465R, 142870 for REF 54-2480R, and 142842 for REF 54-3680R.

Consumers and healthcare providers should check their inventory for these specific reference numbers and lot numbers. If the product matches the recalled items, it should be stopped from use and returned to the supplier or DeRoyal Industries Inc for further instructions.

The recalled product

Product
DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Enteral Feeding 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 (6)

  • a) REF 54-2450R
  • Lot Numbers: 142844
  • 143130 b) REF 54-2465R
  • Lot Numbers: 142843 c) REF 54-2480R
  • Lot Numbers: 142870 d) REF 54-3680R
  • Lot Numbers: 142842

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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