AMT ENFit-to-Stepped Male Adapter Recalled for Incorrect Pouch Labels
Applied Medical Technology Inc is recalling specific lots of ENFit-to-Stepped Male adapters because the inner pouches may have incorrect labels, although the outer boxes are correct.
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 agency classified this as a Class III recall, and the source text identifies the issue as a labeling discrepancy on the inner pouches, which fits the rubric criteria for packaging-only problems or documentation issues.
Plain-English summary
Applied Medical Technology Inc is recalling specific lots of AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapters, Model Number ETRN102. The recall involves Box Lot Number 200918-103 and Pouch Lot Number 200902-075. These products were distributed nationwide in the United States, specifically in California, Georgia, Illinois, Massachusetts, Missouri, Pennsylvania, Texas, and Virginia. No foreign distribution occurred.
The recall was initiated because the products may contain obvious, incorrect labels on the inner pouches, while the outer boxes carry the correct labels. This labeling discrepancy could potentially lead to confusion regarding the product identity or specifications.
Healthcare facilities and consumers who have these specific lot numbers should stop using the affected adapters and contact Applied Medical Technology Inc for further instructions or a replacement. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
- Manufacturer
- Applied Medical Technology Inc
- Hazard
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 (2)
- Box Lot Number 200918-103
- Pouch Lot Number 200902-075
Distribution
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