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Dale ENFit ACE Connector

Dale Medical Products, Inc. · Model 485 · UDI-DI 00817612020261

KNT Prescription
1
510(k) clearances
26,153
Adverse events (631 deaths)
268
Recalls
228
Facilities

Description

The Dale ENFit ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes that use the ENFit connection system. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most ENFit tip syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ENFit ACE Connector is DEHP free and not made with natural latex rubber.

Recalls

DateFirmReason
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
2026-04-30Avanos Medical, Inc.Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

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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.