SSM Health Care St. Louis DBA SSM St. Clare Health Center

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0436-2024Class IIFentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per VialFebruary 29, 2024
D-0435-2024Class IIPhenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/OfFebruary 29, 2024
D-0776-2023Class IIHYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health CarMay 9, 2023
D-0007-2022Class IIPotassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care CoSeptember 22, 2021
D-0145-2018Class IISuccinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injeAugust 10, 2017
D-0138-2018Class IIFentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounAugust 10, 2017
D-0139-2018Class IIHYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., TAugust 10, 2017
D-0142-2018Class IINorepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compoAugust 10, 2017
D-0140-2018Class IIMorphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a August 10, 2017
D-0136-2018Class IIFentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounAugust 10, 2017
D-0143-2018Class IIOxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. ThisAugust 10, 2017
D-0137-2018Class IIAmiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded August 10, 2017
D-0141-2018Class IINeostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injAugust 10, 2017
D-0144-2018Class IIPhenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. ThiAugust 10, 2017