Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope
Jiangsu Shenli Medical has recalled Medline non-sterile syringes because manufactured sizes and configurations exceed the FDA-cleared scope. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a regulatory compliance issue involving medical devices (non-sterile syringes) manufactured in configurations exceeding FDA 510(k) clearance. While no illnesses or injuries have been reported, the product poses a potential risk of harm due to use in unauthorized configurations.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. has recalled Medline brand non-sterile syringes (Model 91879) because the manufacturer produced the device in sizes and configurations that exceed the range cleared under the firm's FDA 510(k) approval.
The syringes were distributed nationwide in the United States, with shipments to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia through major ports and distribution centers.
No illnesses or injuries have been reported in connection with this recall. The recall addresses a manufacturing compliance issue where certain device configurations were produced outside the approved regulatory scope.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- regulatory-non-compliance
- unauthorized-configuration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: LOT: N/A
Distribution
Distributed nationwide across the United States.
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