Syringes with Needles Recalled for Substantial Design Differences from FDA Approval
Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of medical syringes with substantial design differences from FDA-approved specifications. No reported illnesses or injuries are stated in the source, limiting the score to High under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sol-Millennium Medical Inc. is recalling multiple syringe models with fixed and safety needles sold under the brand names SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN. The recalled products include various capacities (1ml, 3ml, 5ml, 10ml) with different needle gauges and configurations, distributed in the United States and internationally to countries including Canada, Mexico, Australia, and across Europe.
The FDA determined that the recalled devices are substantially different from their FDA-cleared designs, with major changes or modifications to their intended use. This means the syringes do not match the specifications that were reviewed and approved by the FDA.
Consumers, healthcare facilities, and retailers who have the affected syringe models should stop using them and consult the FDA website or contact Sol-Millennium Medical Inc. for instructions on returning or properly disposing of the products. The complete list of affected lot numbers and model numbers is available on the FDA website.
Healthcare providers and patients should contact their healthcare provider if they have concerns about syringes they have already used.
The recalled product
- Product
- Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe
- Manufacturer
- Sol-Millennium Medical Inc.
- Hazard
- 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.
Lot numbers (20)
- Model No. 181025
- UPC 818392014884
- Lot Numbers: 4302039
- 4308074
- 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2''
- Model No. 1831815B
- UPC 818392011593
- Lot Numbers: 4103001
- 4106151
- 4111045
- 4304001
- 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2''
- Model No. 1851815B
- UPC 818392011609
- 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2''
- Model No. 1811815B
- UPC 818392011616
- b) SOL-CARE: 1) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 23G*1''
- Model No. 12310SN
- UPC 810018098148
Distribution
Distributed nationwide across the United States.
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