Recall Z-1507-2022— Guangdong Haiou Medical Apparatus Co., Ltd
Class II · Ongoing
Class II FDA medical device recall by Guangdong Haiou Medical Apparatus Co., Ltd, initiated 2022-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25. 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.
- Recalling firm
- Guangdong Haiou Medical Apparatus Co., Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-10
- Firm location
- Puning, China
Product description
Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.