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Amecath Y split catheter

Ameco Medical Industries · Model PYDLC-1450-K · UDI-DI 06221139059484

MSD Prescription
1
510(k) clearances
11,458
Adverse events (302 deaths)
270
Recalls
55
Facilities

Description

Permthane Y split Long term dual lumen catheter kit size 14 Fr tip to cuff length 50 Cm total length 55 Cm

Recalls

DateFirmReason
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-02-13Merit Medical Systems, Inc.16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13Merit Medical Systems, Inc.16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13Merit Medical Systems, Inc.16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13Merit Medical Systems, Inc.16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2025-04-23Mozarc Medical US LLCPotential breach of sterile barrier packaging.
2025-04-23Mozarc Medical US LLCPotential breach of sterile barrier packaging.

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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.