Applied Medical Technology Recalls Nasal Tube Retaining Systems Due to Expired Dates
Applied Medical Technology is recalling 110 units of the AMT Bridle Nasal Tube Retaining System because expired expiration dates are listed on the pouches.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/packaging error (expired dates on pouches) without reported injuries.
Plain-English summary
Applied Medical Technology Inc is recalling 110 units of the AMT Bridle Nasal Tube Retaining System. This medical device is used with Nasogastric/Nasointestinal (NG/NI) tubes. The recall was initiated because expired expiration dates are listed on the pouches.
The affected products were distributed in the United States to the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Louisiana, Maine, Missouri, Minnesota, North Carolina, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Washington, and Wisconsin, as well as to the United Kingdom.
Consumers and healthcare facilities should stop using the affected products and contact Applied Medical Technology Inc for further instructions. The recall involves specific lot numbers and expiration dates detailed in the agency's structured product information.
The recalled product
- Product
- AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
- Manufacturer
- Applied Medical Technology Inc
- Hazard
- Affected units
- 110
Distribution
Part of a larger recall action
This product is one of 2 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.
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