| | Class 2 Device Recall Applied Medical Technology, Inc. |  |
| Date Initiated by Firm | August 12, 2025 |
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| Date Posted | October 09, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0129-2026 |
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| Recall Event ID |
97448 |
| Product Classification |
Tubes, gastrointestinal (and accessories) - Product Code KNT
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| Product | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-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, pediatric, and adult patients. |
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| Code Information |
Box UDI (01)00842071149123(17)280601(10)250711-319, Pouch UDI: (01)00842071149048(17)280601(10)250627-421, (01)00842071149048(17)280601(10)250627-424.
Box UDI (01)00842071149123(17)280601(10)250709-071, Pouch UDI: (01)00842071149048(17)280601(10)250627-422, (01)00842071149048(17)280601(10)250627-423, (01)00842071149048(17)280601(10)250627-130.
Box UDI (01)00842071149123(17)280601(10)250623-205, Pouch UDI: (01)00842071149048(17)280601(10)250612-094, (01)00842071149048(17)280601(10)250617-197, (01)00842071149048(17)280601(10)250610-228.
Box UDI (01)00842071149123(17)280601(10)250625-594, Pouch UDI: (01)00842071149048(17)280601(10)250623-386, (01)00842071149048(17)280601(10)250623-388, (01)00842071149048(17)280601(10)250619-426.
Box UDI (01)00842071149123(17)280601(10)250626-238, Pouch UDI: (01)00842071149048(17)280601(10)250624-271, (01)00842071149048(17)280601(10)250619-353, (01)00842071149048(17)280601(10)250623-389, (01)00842071149048(17)280601(10)250619-425.
Box UDI (01)00842071149123(17)280601(10)250626-342, Pouch UDI: (01)00842071149048(17)280601(10)250624-270.
Box UDI (01)00842071149123(17)280601(10)250616-344, Pouch UDI: (01)00842071149048(17)280601(10)250610-229. |
Recalling Firm/
Manufacturer |
Applied Medical Technology Inc
8006 Katherine Blvd
Brecksville OH 44141-4202
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| For Additional Information Contact | Dan Filler
440-7174000 |
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Manufacturer Reason
for Recall | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. |
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FDA Determined
Cause 2 | Process control |
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| Action | AMT issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 8/12/2025 via USPS certified mail. The notice explained the issue, risk to health and requested the following:
ACTIONS TO BE TAKEN:
CUSTOMER OR USER:
Applied Medical Technology, Inc. requests that customers IMMEDIATELY TAKE THE FOLLOWING ACTIONS:
" Examine your inventory and isolate/quarantine pending return of the product subject to this recall.
" Do not use any device subject to this recall.
" Complete and return to Applied Medical Technology, Inc. the enclosed RECALL NOTIFICATION ACKNOWLEDGMENT via fax or send by mail.
" Please contact Applied Medical Technology, Inc. either by phone at 440-717-4000, or via email at cs@appliedmedical.net, to make arrangements for the return of any devices related to this recall. Include the product, all of its components, and any available packaging and labeling associated with the device. |
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| Quantity in Commerce | 840 units |
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| Distribution | US distribution to MA and RI |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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