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FDAMay 9, 2024device

Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low de...

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

840368511899810018097554810062435319818392018165

Recall history

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

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Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low de... — Recall Details · AllClear