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JEWISH HOSP-DOUBLE LINE/BRIDGE SET

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 687341 · UDI-DI 00886333673414

DXN Prescription
10
510(k) clearances
3,169
Adverse events (16 deaths)
36
Recalls
429
Facilities

Description

2x 3cc transducers, 1x 20 drops, 60" tube Adset & 2x 6" Pressure Tubing, each connected to a port of a 5-Gang Multiport. The middle port connects directly with a 20 drops, 60" Adset. The other 4 ports, each connects with a 6" Pressure Tubing with clamp. The 2 x 3cc transducers are individually connected to these tubings. The zeroing stopcock of transducer in port # 1 connects with a 12" Pressure tubing, with red tape for identification, It has a 72" Pressure tubing connected via s 3-way red stopcocks. Port #2, transducer is connected with a 12" Pressure tubing identified with Yellow tape and a 3-Way yellow stopcock. Port 4 & 5, each connected with 6" pressure Tubing. It also include a TBG, transducer mounting plate

Recalls

DateFirmReason
2025-02-24PYRAMES INCSingle-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. C
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-03-26Baxter Healthcare CorporationBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-03-26Baxter Healthcare CorporationBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-03-26Baxter Healthcare CorporationBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-02-26MEDLINE INDUSTRIES, LP - NorthfieldThe firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. a
2021-05-17Mediana Co., Ltd.In some cases the equipment fails to power up and/or key or button unresponsive or not working.
2021-04-22Welch Allyn IncPotential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

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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.