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
Recall
- Recall Number
- Z-1506-2022
- Event Number
- 90224
- Firm
- Guangdong Haiou Medical Apparatus Co., Ltd Nanyuan Industrial Zone, North Liusha Puning China
- FEI Number
- 3010596027
- Product Code
- MEG
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- June 10, 2022
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
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
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: [email protected] Address: Nanyuan Industrial Zone, North Liusha, Puning City, Guangdong, China
US Nationwide distribution in the state of CA.
4,050,000 units