FDA Device Intelligence
Home › APPLIED MEDICAL TECHNOLOGY, INC. › AMT Enfit® Transition Adapter

AMT Enfit® Transition Adapter

APPLIED MEDICAL TECHNOLOGY, INC. · Model ETRN101 · UDI-DI 00842071107994

PIO Prescription
1
510(k) clearances
404
Adverse events (2 deaths)
3
Recalls
22
Facilities

Description

Male Enfit®-to-Male Luer 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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.