AMT G-Jet Feeding Device Recalled for Length Discrepancy
Applied Medical Technology is recalling 20 units of G-Jet feeding devices because they are shorter than labeled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the issue is a labeling discrepancy regarding product length without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Applied Medical Technology Inc is recalling 20 units of the AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device. The recall was initiated after the firm received complaints that the product is shorter in length than indicated on the label.
The affected devices are Model #GJ-1415-45, Lot # 15104750, with an expiration date of 2018/09. These devices are intended for use in patients who cannot absorb adequate nutrition through the stomach. The products were distributed in the states of Arizona, California, Delaware, Indiana, Michigan, New Mexico, Pennsylvania, and Virginia.
Consumers and healthcare providers should stop using the affected devices and contact Applied Medical Technology Inc for further instructions.
The recalled product
- Product
- AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.
- Manufacturer
- Applied Medical Technology Inc
- Category
- Medical Device — Feeding Devices
- Hazard
- Affected units
- 20
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 (3)
- Model #GJ-1415-45
- Lot # 15104750
- Exp Date: 2018/09
Distribution
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