Class 2 Device Recall HAIOU Needle retractable safety syringe with needle

• Date Initiated by Firm: June 10, 2022
• Create Date: August 05, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1507-2022
• Recall Event ID: 90224
• Product Classification: Syringe, antistick - Product Code MEG
• 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
• Code Information: Lot Number: 20JC2 Exp. Date: 2025/10/17; 21AA0 Exp Date: 2026/01/04
• Recalling Firm/ Manufacturer: Guangdong Haiou Medical Apparatus Co., Ltd; Nanyuan Industrial; Zone, North Liusha; Puning China
• For Additional Information Contact: SAME; 663-2930777
• Manufacturer 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
• FDA Determined Cause: No Marketing Application
• Action: Guangdong Haiou Medical., LTD (Haiou) contacted direct consignee by email on [10-Jun-2022] and Formal Recall Urgent Medical Device Recall letter through email and first-class letter. Letter states reason for recall, health risk and action to take: " Remove product from sale and cease distribution of product subject to this recall action. " Immediately review your inventory for the specific Product Description and Lot Number listed above and place into quarantine until further notice. " Notify us of any stock you have still under your direct control " Notify all customers to whom you have distributed this product of this recall. Use the template provided with this letter. " Complete the attached Customer Response Form and return to the Haiou contact noted on the form whether or not you have any of the impacted material so that Haiou may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. " Forward any customer complaints for the use of this product to Haiou as per the contact information provided. Jiehong Luo QA Manager Phone:+ 86-663-2900999 Email: qc@haiou.net.cn Address: Nanyuan Industrial Zone, North Liusha, Puning City, Guangdong, China
• Quantity in Commerce: 7,218,000 units
• Distribution: US Nationwide distribution in the state of CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.