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

FDA Regulatory Profile

SSM Health Care St. Louis DBA SSM St. Clare Health Center appears in FDA public data with 14 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0436-2024, Class II) was initiated on February 29, 2024.

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-0141-2018Class IINeostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injAugust 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-0144-2018Class IIPhenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. ThiAugust 10, 2017