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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade)

BAYER MEDICAL CARE INC. · Model Stellant FLEX · UDI-DI 00616258020792

IZQDXT Prescription
1
510(k) clearances
576
Adverse events (17 deaths)
3
Recalls
42
Facilities

Description

SYSTEM,DUAL,STELLANT,REMANUFACTURED,FLEX (85631829)

Recalls

DateFirmReason
2011-10-11Mallinckrodt IncSyringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900
2011-05-20Mallinckrodt IncSyringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 9001
2008-04-07Mallinckrodt IncScrews can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.

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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.