Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.
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 unapproved design changes to a cleared medical device. No reported illnesses or injuries are stated in the source text, and the hazard is regulatory non-compliance rather than a known clinical risk, making this a Moderate severity recall.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes. The recall affects approximately 113,843 kits distributed US nationwide, including all 50 states and Barbados.
The firm identified unapproved design changes to the products that were made outside of the FDA 510(k) clearance. These products were not initially reported in prior submission RES 98601.
Affected products include kit model NEURO CSTM (SAMP0551) with UDI-DI 10195327268503 and lot numbers 22JBG593 and 22JBJ361. Consumers and healthcare facilities currently using these kits should stop use and contact Medline Industries, LP for instructions on return or replacement.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Syringes
- Hazard
- regulatory-non-compliance
- unapproved-design-change
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 (1)
- SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361
Distribution
Distributed nationwide across the United States.
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