HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Us
Summary
The FDA issued a Class II for HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-in by Guangdong Haiou Medical Apparatus Co., Ltd. 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.
Details
Source
Device Recall
External ID
Z-1506-2022
Action Date
2022-08-17
Status
Ongoing
Category
device
Product 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
Lot/Code Info: Lot Number: 20IB0 Exp. Date: 2025/09/04
Quantity Affected: 4,050,000 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
Distribution
US Nationwide distribution in the state of CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-10
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 96 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Guangdong Haiou Medical Apparatus Co., Ltd has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Guangdong Haiou Medical Apparatus Co., Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Guangdong Haiou Medical Apparatus Co., Ltd have FDA actions?
Guangdong Haiou Medical Apparatus Co., Ltd has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1506-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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