Medline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 medical device. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is identified as a regulatory/design deviation rather than a direct health threat. Per the rubric, Class II recalls without reported adverse events typically warrant a Moderate severity score.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing select SKUs of 10mL polycarbonate colored syringes (PICC LINEPACK model PCLUI 642-LF, UDI-DI 10193489454529). The manufacturer identified unapproved design changes to the products that fall outside the scope of the FDA 510(k) clearance.
Approximately 113,843 kits have been distributed nationwide across the United States, including all 50 states, as well as to Barbados. The affected product lots include 21CMD153, 21EMC033, 21HMB521, 21HMF278, 21IME100, 21IMG896, 21JMG286, 22AME235, 22BMH056, 22EMF125, 22GMI215, 22JME782, 22LMC139, and 22LMC336 (product code DYNJ47717A).
Healthcare providers and facilities currently using these kits should not use remaining inventory and should contact Medline Industries for instructions on how to proceed. Consumers with questions or concerns about this recall should contact Medline Industries or visit the FDA's Medical Device Recall database for additional information.
The recalled product
- Product
- Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
- Manufacturer
- Medline Industries, LP
Distribution
Part of a larger recall action
This product is one of 16 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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