FDA Device Intelligence
Home › BAYER MEDICAL CARE INC. › MEDRAD® Stellant FLEX Syringe Kit

MEDRAD® Stellant FLEX Syringe Kit

BAYER MEDICAL CARE INC. · Model FLEXD-150-SPK · UDI-DI 00616258010656

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

Description

Stellant Dual 150mL Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (STLNT,KIT,SYR,CT,D,SPK,FLS3,150ML,RW) (85020218)

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.