Zhejiang Kindly Medical Devices Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0204-2022 | Class II | McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS | August 24, 2021 |
| Z-0205-2022 | Class II | McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS | August 24, 2021 |
| Z-0206-2022 | Class II | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS | August 24, 2021 |
| Z-0207-2022 | Class II | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS | August 24, 2021 |
| Z-0209-2022 | Class II | HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 35 | August 24, 2021 |
| Z-0208-2022 | Class II | HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 35 | August 24, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223334 | Sterile Hypodermic Needles for Single Use | December 16, 2022 |
| K213183 | Safety Insulin Pen Needles | October 14, 2022 |
| K181069 | Disposable Insulin Pen Needle | August 28, 2018 |
| K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety | June 4, 2018 |
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | January 5, 2018 |