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CAREFLOW(TM) 1 LUMEN 5FR X 150MM

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 681662 · UDI-DI 00886333616626

FOZ Prescription

510(k) clearances

49,300

Adverse events (141 deaths)

394

Recalls

198

Facilities

Description

Kits Contents : Catheter 5FR OD 1.75mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Overneedle Introducer 16G OD1.7mmx70mm, Dilator 8FR OD 2.69mm ID 0.96mm & Syringe 5ml.

Recalls

Date	Firm	Reason
2026-03-11	ARROW INTERNATIONAL, LLC	Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

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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.