Recall Z-0208-2022 ยท FMI Needle, Hypodermic, Single Lumen
Zhejiang Kindly Medical Devices Co., Ltd.
HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
| Date | Aug 24, 2021 |
| Status | Terminated |
| Reason | Potential for difficulty in safety mechanism activation. |
| Root cause | Nonconforming Material/Component |
| Action | On 8/24/2021, Zhejiang Kindly Medical Devices Co., Ltd. issued Urgent Medical Device Safety Alert notices to two customers. On 9/17/2021, issued a second notice to customers dated 8/24/2021. Action to be Taken by User: 1 - Advise the user to lower the angle between safety protective cap and needle tube by slight pressing in the direction of activation, then using a thumb or hard surface to activate the safety protective cap and lock the needle tube in the IFU, then together with corresponding illustration. 2 - Request the user to strictly follow the guidance of the IFU. |
| Distribution | U.S. Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.