Recall Z-1506-2022 ยท MEG Syringe, Antistick
Guangdong Haiou Medical Apparatus Co., Ltd
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
| Date | Jun 10, 2022 |
| Status | Open, Classified |
| Reason | 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 |
| Root 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 dist |
| Quantity | 4,050,000 units |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.