Disposable Luer Lock Syringes Recalled for Exceeding Cleared Specifications
Jiangsu Shenli Medical recalled approximately 110,000 MEDIGRATIVE disposable syringes because the manufactured units exceed specifications approved by the FDA.
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: FDA Class II recall involving medical devices that deviate from 510(k) cleared specifications. No injuries or illnesses have been reported, but the manufacturing non-compliance represents a risk-of-harm product where actual safety impact has not yet materialized.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. has recalled MEDIGRATIVE brand 100cc/ml disposable luer lock syringes (Model 10025) distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The recalled units, identified by lot codes EJ117-5 through EJ117-11, total approximately 110,000 units.
The FDA determined that the manufactured syringes' sizes and configurations exceed the range of devices approved for the manufacturer under their 510(k) clearance. This regulatory non-compliance means the actual products do not conform to the specifications the FDA reviewed and approved for marketing.
To date, no injuries or adverse events have been reported to the FDA in connection with this recall. Users and healthcare facilities with these syringes should be aware of the recall status.
The recalled product
- Product
- Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- device-specification-mismatch
- manufacturing-defect
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 (7)
- UDI-DI code: 00853620005241 Lot Code: LOT: EJ117-5
- EJ117-6
- EJ117-7
- EJ117-8
- EJ117-9
- EJ117-10
- EJ117-11
Distribution
Distributed nationwide across the United States.
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