MEDLINE non-sterile syringes recalled for out-of-specification piston configuration
Medline is recalling non-sterile syringes with piston sizes and configurations that exceed the FDA-cleared specification range. The affected devices may not function as originally tested and approved.
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 Class II recall for devices with specifications outside the FDA-cleared range, with no reported injuries. This constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Medline is recalling MEDLINE brand SYR 20ML/L WHITE CONTRAST non-sterile syringes without needles (Model 91860, Lot Code 63722080002). Approximately 4,000 units were distributed as part of this recall.
The piston syringe sizes and configurations are outside the range of devices cleared under the manufacturer's 510(k) submission. Devices manufactured outside the scope of FDA clearance may not have been tested for safety and performance as required by regulatory standards.
The affected syringes were distributed nationwide to facilities in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- device-specification-non-compliance
- untested-variant
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: 63722080002
Distribution
Distributed nationwide across the United States.
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