FDAMay 9, 2024device

Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;

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

81001809551810018098605810018098698

Recall history

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

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