Z-3076-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- May 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957
Reason for Recall
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.
Distribution Pattern
US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama
Code Information
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, Lot Numbers: 4105081, 4108076, 4111055, 4302012, 4303050; 7) Model No. P180020ST, UPC 810018098636, Lot Numbers: 4110014, 4110055, 4301004, 4303048; 8) Model No. P180030ST, UPC 810062435333, Lot Numbers: 4302041; 9) Model No. P180060ST, UPC 810062435340, Lot Numbers: 4302042; 10) Model No. P180011T, UPC 810018098957, Lot Numbers: 4108002