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FDAMay 9, 2024device

Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

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

The hazard

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

What to do

FDA enforcement status: Ongoing

Brands named

sol millennium medicalsolsol millennium

UPCs

110101150020

Recall history

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

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