Z-3078-2024 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 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/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only
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
a) Model No. 180011LDS, UPC 840368511899, Lot Numbers: 1102070, 1107062, 2002005, 2006004, 2012008, 2909022, 2911053, 19052401; b) Model No. P180011LDS, UPC 810018097554, Lot Numbers: 4104025, 4104100, 4108014, 4108015, 4108017, 4108095, 4109088, 4202001, 4301003, 4303047, 4312032; c) Model No. 181023L, UPC Sold in Canada Only, Lot Numbers: 4301029; d) Model No. 12558LDS, UPC 810062435319, Lot Numbers: 7210016; e) Model No. P180001PP, UPC 818392018165, Lot Numbers: 4104027, 4104028, 4104029, 4104030, 4104031, 4104032, 4105038, 4106031, 4106032, 4106033, 4106074, 4106075, 4106079, 4106080, 4106081, 4106082, 4106083, 4106086, 8103004, 8104004, 8104006, 8104007, 8104008, 8105038, 8105047, 8105053, 8105054, 8106011, 8106014, 8106024, 8106025, 8106026, 8106027, 8106028, 8106029, 8106030, 8106031, 8106032, 8106033; f) Model No. 181025S, UPC NONE, Lot Numbers: 4110059, 4110091, 4110092, 4212021, 4303009, 4303010, 4303011, 4303012, 4304016,