Stradis Healthcare

FDA Regulatory Profile

Summary

Total Recalls
71
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0943-2023Class IIMcCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical DistrDecember 15, 2022
Z-0944-2023Class IIStradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.December 15, 2022
Z-0933-2023Class IIHenry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.December 15, 2022
Z-0940-2023Class IIHCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care TechnologyDecember 15, 2022
Z-0937-2023Class IIHCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. DistributDecember 15, 2022
Z-0939-2023Class IIHCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.December 15, 2022
Z-0948-2023Class IIVital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.December 15, 2022
Z-0934-2023Class IIHenry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 PairsDecember 15, 2022
Z-0931-2023Class IIStradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, SterileDecember 15, 2022
Z-0941-2023Class IIHCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care TechnologyDecember 15, 2022
Z-0946-2023Class IITacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. MaDecember 15, 2022
Z-0942-2023Class IIStradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis HealthcareDecember 15, 2022
Z-0945-2023Class IITacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. ManufactureDecember 15, 2022
Z-0947-2023Class IITacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.December 15, 2022
Z-0932-2023Class IIPHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.December 15, 2022
Z-0935-2023Class IIPICC KIT, 10/CS, ACCESS MEDICAL LABELDecember 15, 2022
Z-0938-2023Class IIHCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care TechnologyDecember 15, 2022
Z-0936-2023Class IIHCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed bDecember 15, 2022
Z-1688-2022Class IIVYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CSMay 10, 2022
Z-1132-2022Class IISurgical Suture KitApril 22, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K161483Unger Quad InjectorOctober 31, 2016