Medline Non-Sterile Syringes Recalled for Out-of-Specification Manufacturing
Medline brand non-sterile 5mL syringes (Model 91828) are being recalled because the piston syringe sizes and configurations exceed the manufacturer's FDA 510(k) clearance specifications. The recall affects 22,400 units distributed nationwide.
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 FDA Class II recall involves devices manufactured outside their cleared specifications, which poses a risk of device malfunction or improper performance. No illnesses or injuries have been reported.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand non-sterile 5mL syringes without needles (Model 91828) due to regulatory non-compliance. The recalled syringes have piston sizes and configurations that exceed the range of devices cleared under the manufacturer's 510(k) premarket notification to FDA.
The recall affects 22,400 syringes distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot codes are: 63721090001, 63722020002, 63722030001, 63722100003, 63723030001, 63723060001, and 63723070001.
Customers who have received these syringes should immediately stop using them and contact Jiangsu Shenli Medical Production Co., Ltd. or the point of purchase for instructions on return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- out-of-specification
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 (7)
- Lot Code: LOT: 63721090001
- 63722020002
- 63722030001
- 63722100003
- 63723030001
- 63723060001
- 63723070001
Distribution
Distributed nationwide across the United States.
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