Medline 5ML Heparin Syringes Recalled for Specification Non-Compliance
Medline 5ML heparin syringes (Model 91867) are being recalled because the syringe sizes and configurations do not match the range of products approved by the FDA. No injuries or illnesses 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 an FDA Class II recall for medical devices that do not conform to FDA-approved specifications. While no injuries or illnesses have been reported, non-compliance with approved device specifications represents a risk of harm to users.
Plain-English summary
Medline 5ML heparin syringes (Model 91867), manufactured by Jiangsu Shenli Medical Production Co., Ltd., are being recalled. The recall affects 2,800 units with lot code 63723010001.
The syringes are being recalled because the device sizes and configurations do not conform to the range of products cleared by the FDA under the manufacturer's 510(k) approval. This means the actual products deviate from the FDA-reviewed and approved specifications.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. No illnesses or injuries have been reported in connection with these products. Customers should contact the manufacturer for guidance on handling affected inventory.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- device-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 (1)
- Lot Code: LOT: 63723010001
Distribution
Distributed nationwide across the United States.
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