MEDLINE SYR 60ML Non-Sterile Syringes Recalled for Clearance Violation
Jiangsu Shenli Medical is recalling 1,117,800 MEDLINE SYR 60ML non-sterile syringes (Model 83080) because certain syringe sizes and configurations exceed what was approved under the manufacturer's FDA 510(k) clearance.
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 involving regulatory non-compliance; the devices exceed what was approved under the manufacturer's 510(k) clearance. No illnesses or injuries are reported, making this a precautionary compliance-focused recall.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd., is recalling 1,117,800 units of MEDLINE SYR 60ML L/L non-sterile syringes (Model 83080). These single-use syringes without needles were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
The syringes are being recalled because certain syringe sizes and configurations fall outside the range of products cleared by the FDA under the manufacturer's 510(k) submission. This means these specific configurations were not included in the FDA's review and approval of the product.
Healthcare providers and patients in the affected states should stop using these syringes. Check with your medical device supplier for replacement products. The affected lot numbers are listed in the FDA recall notice. Report any adverse events or injuries associated with these syringes to the FDA's MedWatch program at [email protected].
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- clearance-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 (20)
- Lot Code: LOT: 63720120007
- 63721010002
- 63721040002
- 63721050002
- 63721060001
- 63721060002
- 63721070001
- 63721070004
- 63721070006
- 63721080001
- 63721080004
- 63721080005
- 63721090001
- 63721100001
- 63721100002
- 63721110001
- 63721110002
- 63721110003
- 63721120001
- 63721120003
Distribution
Distributed nationwide across the United States.
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