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Amecath dual lumen catheter

Ameco Medical Industries · Model PDLC-15.531-K · UDI-DI 06221139123796

MSD Prescription
1
510(k) clearances
11,428
Adverse events (301 deaths)
270
Recalls
55
Facilities

Description

Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 31 Cm total length 36 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.