Device product
HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-25G25
Z-1506-2022
Product summary
- Event
- Event 90224
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,050,000 units
- Official record key
device-enforcement:Z-1506-2022
Official wording
Reason: Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user
Code information: Lot Number: 20IB0 Exp. Date: 2025/09/04
Distribution pattern: US Nationwide distribution in the state of CA.
Derived failure modes
-
Unknown
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user