Larger nasal feeding tubes recalled because distal tips may detach
Applied Medical Technology is recalling 200 NutraGlide 5 F - 8 F nasal feeding tubes whose distal tips may detach at lower than expected forces.
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: Scored 3 under the risk-of-harm criterion: a feeding tube tip that can detach inside a patient is a physical hazard, and no injuries are reported.
Plain-English summary
NutraGlide Nasal Feeding Tubes with stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I, are being recalled. The tube is placed through the nose and ends in the stomach or intestine, and is used for the administration of nutrition and fluids.
The affected tubes have distal tips that may detach at lower than expected forces.
The recall covers 200 units, with box UDI (01)00842071149161(17)280501(10)250616-082 and pouch UDI (01)00842071149086(17)280601(10)250604-073, distributed to Massachusetts and Rhode Island. The FDA has classified the action as Class II.
The enforcement record describes the detachment potential and reports no injuries. Facilities should quarantine affected stock and follow the firm's instructions.
The recalled product
- Product
- NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
- Manufacturer
- Applied Medical Technology Inc
- Category
- Medical Device — Feeding tube
- Affected units
- 200
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 (4)
- Box UDI (01)00842071149161(17)280501(10)250616-082
- Pouch UDI (01)00842071149086(17)280601(10)250604-073
- Pouch UDI (01)00842071149086(17)280601(10)250609-271
- (01)00842071149086(17)280601(10)250610-219.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Applied Medical Technology 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 4 products in this recall →Related recalls
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- HighNinety centimetre nasal feeding tubes recalled for possible occlusion
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