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Disposable MRI Kit for 65/115 MR Injector System

BAYER MEDICAL CARE INC. · Model SSQK 65/115VS · UDI-DI 00616258007786

DXT Prescription
10
510(k) clearances
3,315
Adverse events (146 deaths)
69
Recalls
123
Facilities

Description

Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1 large spike, 1 small spike for contrast, 96" low pressure tubing with T-connector and Check Valve) (KIT,65/115ML,96" CT/CV,MRI,CHINA) (60728591)

Recalls

DateFirmReason
2026-04-24Bayer Medical Care, Inc.Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock c
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2024-08-30Merit Medical Systems, Inc.Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
2024-08-30Merit Medical Systems, Inc.Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
2024-08-30Merit Medical Systems, Inc.Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

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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.