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Nurse Assist, Inc

FDA Regulatory Profile

Summary

Total Recalls
6 (6 Class I)
510(k) Clearances
4
Inspections
7
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0515-2024Class ISterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6November 6, 2023
Z-0512-2024Class I0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240November 6, 2023
Z-0511-2024Class I0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NUNovember 6, 2023
Z-0514-2024Class ISterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STENovember 6, 2023
Z-0513-2024Class ISterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLENovember 6, 2023
Z-0926-2017Class INormal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill.October 4, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride August 11, 2020
K150143Normal Saline FlushAugust 31, 2015
K121390LUBE JELLY SURINGEAugust 10, 2012
K083042WOUND FLUSH, STERILE WATER & NORMAL SALINEDecember 18, 2008