The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
1) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBK394; 2) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBN659; 3) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO446; 4) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO586; 5) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBQ523
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.