FDA recall Z-1507-2022

Guangdong Haiou Medical Apparatus Co., Ltd · Class II · device

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 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

US Nationwide distribution in the state of CA.

Key facts

Status
Ongoing
Initiation date
2022-06-10
Report date
2022-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Puning, China

Primary source

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