Medline Non-Sterile Syringes Recalled for Configuration Outside FDA Clearance
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
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: Class II FDA recall for syringes with configurations outside 510(k) clearance scope, representing a risk-of-harm product. No illnesses or injuries reported, but devices operating outside tested specifications could compromise medication delivery and device performance.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline-branded SYR 3ML L/L RED non-sterile syringes without needles (Model 91820). The recall affects units distributed nationwide to California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The recalled syringes have piston syringe sizes and configurations that exceed the range of devices cleared under the manufacturer's FDA 510(k) submission. Devices operating outside their tested parameters could potentially malfunction or fail to function as intended.
Consumers and healthcare facilities using these syringes should discontinue use immediately. Return unused product to your distributor or contact Jiangsu Shenli Medical Production Co., Ltd. for instructions on proper disposal and replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 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
- out-of-specification
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: N/A
Distribution
Distributed nationwide across the United States.
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