Multiple Syringe Models Recalled for Deviation from FDA Clearance Specifications

Plain-English summary

Sol-Millennium Medical Inc. is recalling multiple models of SOL-M and SOL-CARE syringes with low dead space. The recalled products include SOL-M Slip Tip syringes (Models 180011LDS and P180011LDS), SOL-M Luer Lock Syringe with Exchange Needle (Model 181023L), SOL-CARE Luer Lock Syringe with Safety Needle (Model 12558LDS), SOL-M Luer Lock Syringe without Needle (Model P180001PP), and SOL-M TB Slip Tip Syringe with Exchange Needle (Model 181025S).

The FDA determined that the distributed products are substantially different from the FDA-cleared 510(k) specifications, with major changes or modifications to the device's intended use. These deviations mean the syringes do not comply with their cleared design and specifications.

The affected syringes were distributed nationwide in the United States and internationally, including to countries such as Canada, the United Kingdom, Belgium, France, Germany, Spain, Italy, Portugal, and others. Specific lot numbers for each model are listed in the FDA recall documentation.

Patients and healthcare providers who have received these syringes should consult the FDA recall notice Z-3078-2024 for complete model and lot number information and for guidance on product handling and disposition.

The recalled product

Product

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/Ex

Manufacturer

Sol-Millennium Medical Inc.

Category

Medical Device — Syringes

Hazard

• specification-non-compliance
• design-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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