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AMT Enfit® Transition Adapter

APPLIED MEDICAL TECHNOLOGY, INC. · Model ETRN201 · UDI-DI 00842071108014

PIO Prescription
1
510(k) clearances
404
Adverse events (2 deaths)
3
Recalls
21
Facilities

Description

Female Luer/Oral-to-Female Enfit® Adapter (Pouched)

Recalls

DateFirmReason
2026-02-13Medline Industries, LPConnectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in
2026-02-13Medline Industries, LPConnectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in
2020-11-10Applied Medical Technology IncThe products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.