Nasal feeding tubes recalled for distal tip detachment risk
Applied Medical Technology is recalling 1,780 NutraGlide nasal feeding tubes because distal tips may detach at lower than expected forces. The affected tubes were distributed to Massachusetts and Rhode Island.
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: This is an FDA Class II recall with no reported illnesses or injuries documented in the source. The hazard is a mechanical failure (distal tip detachment) that poses a risk of harm but has not yet caused documented injury. Per the severity rubric, risk-of-harm products where injury has not yet been reported are rated at most 3 (High).
Plain-English summary
Applied Medical Technology Inc is recalling NutraGlide Nasal Feeding Tubes, model 5 F-6 F x 55 (REF E NRT-05055-I). Approximately 1,780 units are affected by this recall.
These tubes are designed to be placed through the nose and ending in the stomach or intestine for administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
The recalled tubes have distal tips that may detach at lower than expected forces.
The affected tubes were distributed in the United States, specifically to Massachusetts and Rhode Island.
The recalled product
- Product
- NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-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 Tubes
- Hazard
- distal-tip-detachment
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)
- Box UDI (01)00842071149628(17)280601(10)250711-237
- Pouch UDI: (01)00842071149505(17)280701(10)250707-412
- Pouch UDI: (01)00842071149505(17)280701(10)250710-247
- Pouch UDI: (01)00842071149505(17)280701(10)250702-222
- (01)00842071149505(17)280601(10)250627-420
- Pouch UDI: (01)00842071149505(17)280701(10)250702-169
- (01)00842071149505(17)280701(10)250702-138
- (01)00842071149505(17)280701(10)250702-220
- (01)00842071149505(17)280601(10)250630-093
- (01)00842071149505(17)280601(10)250630-048
- (01)00842071149505(17)280601(10)250630-047
- (01)00842071149505(17)280601(10)250630-046
- Pouch UDI: (01)00842071149505(17)280701(10)250707-457
- (01)00842071149505(17)280701(10)250702-414
- (01)00842071149505(17)280601(10)250701-302
- (01)00842071149505(17)280601(10)250701-301
- Pouch UDI: (01)00842071149505(17)280601(10)250617-066
- (01)00842071149505(17)280601(10)250617-067
- Pouch UDI: (01)00842071149505(17)280601(10)250609-360
- (01)00842071149505(17)280601(10)250604-076
Distribution
Distributed in 2 states:
- MA
- RI
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