Nurse Assist, Inc
FDA Regulatory Profile
Nurse Assist, Inc appears in FDA public data with 6 recalls — including 6 Class I (most serious) —, 4 510(k) clearances, 7 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-0515-2024, Class I) was initiated on November 6, 2023. Its most recent 510(k) clearance was granted on August 11, 2020.
Summary
- Total Recalls
- 6 (6 Class I)
- 510(k) Clearances
- 4
- Inspections
- 7
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0515-2024 | Class I | Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6 | November 6, 2023 |
| Z-0511-2024 | Class I | 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NU | November 6, 2023 |
| Z-0512-2024 | Class I | 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 | November 6, 2023 |
| Z-0514-2024 | Class I | Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STE | November 6, 2023 |
| Z-0513-2024 | Class I | Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE | November 6, 2023 |
| Z-0926-2017 | Class I | Normal 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-Number | Device | Date |
|---|
| K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride | August 11, 2020 |
| K150143 | Normal Saline Flush | August 31, 2015 |
| K121390 | LUBE JELLY SURINGE | August 10, 2012 |
| K083042 | WOUND FLUSH, STERILE WATER & NORMAL SALINE | December 18, 2008 |