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Assurance Infusion

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0673-2020Class IIBAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-88December 20, 2019
D-0777-2020Class IITRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800December 20, 2019
D-0733-2020Class IIFENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0736-2020Class IIHCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800December 20, 2019
D-0744-2020Class IIHYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0702-2020Class IIBUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0719-2020Class IIBUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0696-2020Class IIBUP 23MG/HYDROM 25MG/SUF 100MCG/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-0712-2020Class IIBUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) 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-0750-2020Class IIMORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019
D-0701-2020Class IIBUP 30MG/ MORP 8MG/ML 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-0674-2020Class IIBAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800December 20, 2019