NutraGlide Nasal Feeding Tube recalled due to detachable distal tips
Applied Medical Technology is recalling NutraGlide Nasal Feeding Tubes because the distal tips may detach at lower than expected forces. The tubes are used for nutrition and medication administration in neonatal, pediatric, and adult patients.
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 a Class II medical device recall of a risk-of-harm product used in vulnerable populations (neonatal and pediatric patients). While the defect could interfere with critical nutrition delivery, the source text documents no reported illnesses or injuries. Per the severity rubric, risk-of-harm products with no reported injury score as High (3).
Plain-English summary
Applied Medical Technology Inc. is recalling the NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90 (REF E NRT-05090-I). The distal tips of the affected tubes may detach at lower than expected forces.
The NutraGlide Nasal Feeding Tube is placed through the nose and ending in the stomach or intestine for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. A detachable distal tip could interfere with the tube's intended function and nutrition delivery.
The recall affects 390 units distributed to Massachusetts and Rhode Island. Affected tubes can be identified by their UDI codes, which are documented in the FDA recall notice.
The recalled product
- Product
- NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-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
- 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 (7)
- Box UDI (01)00842071149666(17)280601(10)250626-382
- Pouch UDI: (01)00842071149543(17)280501(10)250529-090
- (01)00842071149543(17)280501(10)250529-091
- (01)00842071149543(17)280501(10)250529-092
- (01)00842071149543(17)280501(10)250529-093
- (01)00842071149543(17)280501(10)250529-094
- (01)00842071149543(17)280501(10)250529-095.
Distribution
Distributed in 2 states:
- MA
- RI
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