Medline 10mL Syringes Recalled Due to Non-Conforming Device Configuration
Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.
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: FDA Class II recall of medical syringes, which are risk-of-harm products. The devices have configurations outside FDA-cleared scope, representing a substantive safety concern. No reported illnesses or injuries, but the regulatory non-conformance warrants high severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling non-sterile Medline 10-milliliter syringes without needles (Model 91872, lot codes 63721040002, 63721100001, 63722100003, 63723070001, and 63723100003) distributed across the United States.
The syringes have sizes and configurations that fall outside the range of devices cleared by the Food and Drug Administration under the manufacturer's 510(k) premarket notification. This means the specific configurations of these devices were not evaluated or approved by the FDA, creating a regulatory non-compliance issue.
The affected devices were distributed nationwide to California, Florida, Georgia, Illinois, Tennessee, and Virginia. Distribution occurred through major port facilities including Shanghai, Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers who possess these devices should stop using them immediately. Anyone who has used these syringes and has concerns about adverse reactions should contact their healthcare provider. Healthcare facilities and retail distributors should quarantine the affected inventory and arrange return or replacement.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- regulatory-non-compliance
- device-configuration-deviation
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 (5)
- Lot Code: LOT: 63721040002
- 63721100001
- 63722100003
- 63723070 001
- 63723100003
Distribution
Distributed nationwide across the United States.
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