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AMSure® Enteral Irrigation Kit with Piston Syringe

AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411008491

KNT Prescription

510(k) clearances

26,153

Adverse events (631 deaths)

268

Recalls

228

Facilities

Description

AMSure® Enteral Irrigation Kit with Piston Syringe Clean, Ready to Use For Single Patient Use Only CONTENTS: • Graduated Container, 500 ml • 1 Piston Irrigation Syringe, 60 ml • 1 Patient I.D. Label • 1 Luer Tip Adapter

Recalls

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