Medline 10ML Syringes Recalled Due to Regulatory Specification Non-Compliance
Medline is recalling 10ML syringes in multiple lot codes because the device sizes fall outside the range cleared by the FDA for this product. The affected products were distributed to consumers in six states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for regulatory non-compliance: the device sizes are outside the range cleared under the firm's 510(k) approval. No illnesses or injuries have been reported, and the hazard is preventive in nature, fitting the definition of a voluntary precautionary recall.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand SYR 10ML L/L YELLOW CONT non-sterile syringes without needles (Model 91846). The recall affects 25,200 units with lot codes 63721110001, 63722100003, 63723030001, and 63723090002.
The syringes are being recalled because their sizes and configurations exceed the range of devices approved by the FDA under the manufacturer's 510(k) clearance. This means the specific dimensions and design of these syringes were not reviewed and cleared by the FDA.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Consumers who have these products should stop using them and contact their healthcare provider or Medline for instructions on return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- regulatory-non-compliance
- device-not-cleared
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 (4)
- Lot Code: LOT: 63721110001
- 63722100003
- 63723030001
- 63723090 002
Distribution
Distributed nationwide across the United States.
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