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FDAMay 9, 2024device

Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CAR...

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

818392010268818392010275818392010244818392010251818392010237818392011586818392010114818392010084818392010091818392010039818392010077818392010107

Recall history

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

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Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CAR... — Recall Details · AllClear