FDA-Device2022-08-17Class II

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

Guangdong Haiou Medical Apparatus Co., Ltd
Hazard

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

Sold states
US Nationwide distribution in the state of CA.
Affected count
7,218,000 units
Manufactured in
Nanyuan Industrial, Zone, North Liusha, Puning, China
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1507-2022

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