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
FDA Recall Z-1507-2022 · Posted None
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Recalling FirmGuangdong Haiou Medical Apparatus Co., Ltd
Recall StatusOpen, Classified
Product CodeMEG
Date Initiated2022-06-10
Product Quantity7,218,000 units
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
Firm 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: [email protected]
Address: Nanyuan Industrial Zone,
North Liusha, Puning City, Guangdong, China
Root Cause
No Marketing Application
Distribution Pattern
US Nationwide distribution in the state of CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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