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CAREFLOW(TM) 1 LUMEN 4FR X 200MM
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 681659 · UDI-DI 00886333616596
FOZ
Prescription
10
510(k) clearances
49,300
Adverse events (141 deaths)
394
Recalls
199
Facilities
Description
Kits Contents : Catheter 4FR OD 1.45mmx200mm; J guidewire OD 0.46mmx650mm, Steel Needle Introducer 22G OD 0.75mmx40mm, Dilator 5FR OD 1.7mm ID 0.66mm & 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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Get your free API keyRead the docsData 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.