MEDLINE 5ML Syringes Recalled for Non-Compliance with FDA Clearance
Jiangsu Shenli Medical is recalling MEDLINE non-sterile 5ML syringes (Model 91826) because certain sizes and configurations exceed the range cleared by the FDA. The company is notifying customers and arranging product retrieval.
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 recall involves a risk-of-harm medical device with specifications outside FDA-cleared parameters, with no illnesses or injuries reported. The device specification non-compliance represents a potential rather than confirmed clinical risk.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling MEDLINE brand SYR 5ML L/L GREEN non-sterile syringes without needles (Model 91826) due to a regulatory compliance failure. The recalled syringes have piston sizes and configurations that fall outside the range of devices cleared under the firm's FDA 510(k) premarket notification.
The recall affects approximately 25,200 units distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected product is identified by Lot Codes 63720120007 and 63721070001.
Customers who received these syringes should stop using them and contact Jiangsu Shenli Medical Production Co., Ltd. or their distribution partner for instructions on product return. Healthcare facilities and pharmacies should quarantine affected inventory pending further guidance from the manufacturer.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- device-specification-defect
- regulatory-non-compliance
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 (2)
- Lot Code: LOT: 63720120007
- 63721070001
Distribution
Distributed nationwide across the United States.
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