Assurance Infusion

FDA Regulatory Profile

Assurance Infusion appears in FDA public data with 118 recalls, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (D-0723-2020, Class II) was initiated on December 20, 2019.

Summary

Total Recalls
118
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0723-2020Class IICLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0767-2020Class IISUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0751-2020Class IIMORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0727-2020Class IIFENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0667-2020Class IIBAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0718-2020Class IIBUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0743-2020Class IIHYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0711-2020Class IIBUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0691-2020Class IIBUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0754-2020Class IIMORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0730-2020Class IIFENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0666-2020Class IIBAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0676-2020Class IIBACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0725-2020Class IICLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0769-2020Class IISUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0692-2020Class IIBUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0776-2020Class IITRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0662-2020Class IIAlprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800December 20, 2019
D-0773-2020Class IITRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800December 20, 2019
D-0678-2020Class IIBi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800December 20, 2019