FDAMay 29, 2024device

Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurologica...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

What to do

FDA enforcement status: Ongoing

Brands named

cardinal health 200cardinalcardinal health

UPCs

501971062282561019710622825850888439733509108884397335015019559432556310195594325565501955946225321019559462253450888439636374108884396363765019559481211710195594812119

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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