The Recall Desk
HighFDA (Devices)·Z-0093-2019·Announced 2018-10-17

NeoMed Enteral Feeding Tubes Recalled for Tethered Plug Defect

Neomed Inc is recalling NeoMed Enteral Feeding Tubes because the tethered plug may inadvertently open after closure, potentially compromising the device's seal.

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 is classified as FDA Class II, and the hazard involves a medical device defect that poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Neomed Inc is recalling NeoMed Enteral Feeding Tubes with Enteral Only Connectors in French sizes 4.0Fr, 5.0Fr, 6.5Fr, and 8.0Fr, and lengths 40cm, 60cm, and 90cm. The recall involves 208,260 units (20,826 cases) distributed worldwide, including nationwide in the United States and in Australia, Canada, Singapore, and Spain. The product consists of a polyurethane feeding tube with an attached hub and tethered plug intended for use in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.

The recall was initiated due to a potential for the tethered plug on the hub to inadvertently open after closure. This defect could compromise the integrity of the device's seal when the feeding tube is not in use. The agency has classified this recall as Class II.

Healthcare facilities and consumers should stop using the affected devices and contact Neomed Inc for further instructions. The specific lot numbers and model numbers affected are listed in the official recall documentation.

The recalled product

Product
NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. P
Manufacturer
Neomed 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 (20)

  • Model Number (Lot Numbers): FTS5.0P EO (20170731
  • 20170804
  • 20170813
  • 20170914
  • 20171011
  • 20171018
  • 20171128
  • 20180108
  • 20180125)
  • FTM5.0P EO (20170818
  • 20170904
  • 20170915
  • 20171009
  • 20171130
  • 20171204
  • 20171227
  • 20180205
  • 20180317)
  • FTL5.0P EO (20170816
  • 20180115)

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

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