Non-sterile Piston Syringes Distributed Outside FDA-Approved Specifications
Medline piston syringes (Model 83083) manufactured by Jiangsu Shenli are being recalled because their sizes and configurations fall outside FDA-approved specifications. Approximately 494,000 units are affected across the United States.
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: The recalled devices fall outside the parameters of FDA 510(k) clearance, making them risk-of-harm products where safety and effectiveness have not been verified. The FDA Class II status and manufacturing non-conformance justify a high-severity classification per the rubric criterion for risk-of-harm products.
Plain-English summary
Medline piston syringes (Model 83083, SYR 3ML L/S) manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled. The manufactured syringe sizes and configurations fall outside the range of devices that were cleared under the manufacturer's FDA 510(k) submission.
Approximately 494,000 units have been distributed throughout the United States, with distribution in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The affected lot codes are: 63721010004, 63721020002, 63721040002, 63721050002, 63721060001, 63721070001, 63721080001, 63721090001, 63721110001, 63721120001, 63722010001, 63722020003, 63722030001, 63722050006, 63722060001, 63722070005, 63722080002, 63722090002, 63722100003, 63722120002, 63723020001, 63723030001, 63723060001, 63723070001, 63723090002, 63723100003, 63723120002.
Healthcare providers and consumers with syringes from these lot codes should stop using them and contact their supplier for return or replacement instructions.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- specification-deviation
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 (20)
- Lot Code: LOT: 63721010004
- 63721020002
- 63721040002
- 63721050002
- 63721060001
- 63721070001
- 63721080001
- 63721090001
- 63721110001
- 63721120001
- 63722010001
- 63722020003
- 63722030001
- 63722050006
- 63722060001
- 63722070005
- 63722080002
- 63722090002
- 63722100003
- 63722120002
Distribution
Distributed nationwide across the United States.
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