Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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. 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. Open the enforcement explorer →