Medline non-sterile syringes recalled for out-of-specification manufacturing
Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
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 of a medical device with regulatory non-compliance. No illnesses or injuries have been reported. The hazard is theoretical—devices outside cleared specifications present a potential risk of malfunction, but without reported harm, this meets the rubric criterion for High (3) severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand non-sterile syringes without needles (Model 91862, SYR 20ML/L WHITE HEP FLUSH). The recall involves 400 units with lot code 63722030001.
The syringes are being recalled because their sizes and configurations are outside the range of devices cleared by the FDA under the manufacturer's 510(k) application. This means the devices do not meet FDA-approved specifications for safety and performance.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- device-malfunction
- specification-violation
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: 63722030001
Distribution
Distributed nationwide across the United States.
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