Z-1506-2022 Class II Ongoing
FDA device recall Z-1506-2022 was initiated by Guangdong Haiou Medical Apparatus Co., Ltd on June 10, 2022 and is designated Class II. Reason for recall: 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 ri… The recall status is ongoing. Affected quantity: 4,050,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2022
- Initiation Date
- June 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,050,000 units
Product Description
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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the state of CA.
Code Information
Lot Number: 20IB0 Exp. Date: 2025/09/04