SOL-CARE and SOL-M syringes recalled for unapproved design modifications
Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.
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 an FDA Class II recall for devices found to be substantially different from their cleared design with major modifications to intended use. The recall addresses regulatory non-compliance of a device type (syringes with safety features) where modifications to intended use represent risk-of-harm to users, with no injuries yet reported.
Plain-English summary
Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M brand syringes with safety needles because these devices are substantially different from the FDA-cleared versions. The modifications constitute a major change to the devices' intended use. Affected products are distributed nationwide and internationally, including in Canada, the United Kingdom, Australia, Mexico, and dozens of other countries.
The recalled products include multiple models ranging from 1ml to 10ml in volume, with needle gauges from 21G to 30G. Specific affected lot numbers are provided by the FDA for SOL-M, SOL-CARE, and Henry Schein brand syringes. Healthcare providers and consumers should check the lot numbers of any syringes in their inventory against the FDA's published list.
The FDA has not disclosed the specific modifications or the exact nature of the change to intended use. Consumers and healthcare facilities with recalled products should contact Sol-Millennium Medical Inc. or the product distributor for further instructions and clarification.
The recalled product
- Product
- 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
- Manufacturer
- Sol-Millennium Medical Inc.
- Hazard
- device-modification
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)
- a) SOL-M: 1) Model No. 1812010
- UPC 818392010268
- Lot Numbers: 4202007
- 2) Model No. 1812015
- UPC 818392010275
- Lot Numbers: 4110010
- 3) Model No. 1812110
- UPC 818392010244
- Lot Numbers: 4202008
- 4) Model No. 1812115
- UPC 818392010251
- Lot Numbers: 2108094
- 4110087
- 4110088
- 4303013
- 4303015
- 4304027
- 4311001
- 4312014
- 4312022
Distribution
Distributed nationwide across the United States.
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