Dynarex Corporation

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
8
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1955-2018Class IIDynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 6167845May 8, 2018
Z-2057-2016Class IIdynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use March 3, 2016
Z-2117-2014Class IICPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case -July 2, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K172266Dynarex Three-Way StopcockMarch 14, 2018
K152970Dynarex Xeroform Petrolatum DressingOctober 3, 2016
K151575Dynarex Eye CupsSeptember 1, 2015
K103086DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRICJune 7, 2011
K102637DYNAREX ULTRASOUND GELFebruary 16, 2011
K092488DYNAREX STERILE LUBRICATING JELLYDecember 18, 2009
K082863DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND January 9, 2009
K081569DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY September 12, 2008