Syringes with Luer Slip Tips Recalled for Unapproved Design Modifications
Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.
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 medical device used for injections with modifications to its FDA-approved design and intended use. Although no illnesses or injuries have been reported, syringes are inherently high-risk products, and unapproved modifications to their specifications constitute a risk-of-harm situation.
Plain-English summary
Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models, distributed nationwide and internationally. Affected products include 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, and 60ml sizes with model numbers 180011, P180011, 180020ST, P180003ST, P180005ST, P180010ST, P180020ST, P180030ST, P180060ST, and P180011T, along with specific lot numbers designated for each model.
The FDA determined that these products are substantially different from their current FDA-cleared 510(k) specifications and contain major changes or modifications to the device's intended use. The syringes were originally cleared for specific designs and purposes, and the products in distribution do not match those approved specifications.
These syringes are used in healthcare settings and by individuals for medication delivery and injections. Healthcare providers and patients currently using affected lots should discontinue use immediately and contact their healthcare provider or the manufacturer for guidance on obtaining replacement products.
The recalled product
- Product
- Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 8403685
- Manufacturer
- Sol-Millennium Medical Inc.
- Category
- Medical Device — Syringe
- Hazard
- unapproved-modification
- specification-variance
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)
- 1) Model No. 180011
- UPC 8183923010138
- Lot Numbers: 19072506
- 2) Model No. P180011
- UPC 810018097523
- Lot Numbers: 4107175
- 4107176
- 4110015
- 4312056
- 3) Model No. 180020ST
- UPC 840368511998
- Lot Numbers: 4209011
- 4) Model No. P180003ST
- UPC 810018097493
- Lot Numbers: 4105121
- 5) Model No. P180005ST
- UPC 810018097462
- Lot Numbers: 4104054
- 6) Model No. P180010ST
- UPC 810018097646
Distribution
Distributed nationwide across the United States.
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