Chrysalis Intelligence · Sponsors · Zhejiang Kindly Medical Devices Co., Ltd.

Zhejiang Kindly Medical Devices Co., Ltd.

Wenzhou, CN · 2 510(k) clearances · 6 recalls

Total clearances
2
2022-10-14 → 2022-12-16
Last 12 months
0
Product codes
1
Most recent
2022-12-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FMI Needle, Hypodermic, Single Lumen Class II General Hospital 2 2022-12-16
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
0
Most recent
2021-08-24
DateSeverityStatusRecall # ProductCodeReason
2021-08-24 Class II Terminated Z-0209-2022 HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm Potential for difficulty in safety mechanism activation.
2021-08-24 Class II Terminated Z-0208-2022 HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm Potential for difficulty in safety mechanism activation.
2021-08-24 Class II Terminated Z-0207-2022 McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS Potential for difficulty in safety mechanism activation.
2021-08-24 Class II Terminated Z-0206-2022 McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS Potential for difficulty in safety mechanism activation.
2021-08-24 Class II Terminated Z-0205-2022 McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS Potential for difficulty in safety mechanism activation.
2021-08-24 Class II Terminated Z-0204-2022 McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS Potential for difficulty in safety mechanism activation.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2022-12-16 K223334 Sterile Hypodermic Needles for Single Use FMI Class II General Hospital
2022-10-14 K213183 Safety Insulin Pen Needles FMI Class II General Hospital