Medline Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a fundamental regulatory violation (unapproved design changes outside 510(k) clearance), which creates risk of harm given that syringes are safety-critical medical devices used in clinical settings. Class II recalls are assigned a minimum score of 4 when they involve design or function defects.
Plain-English summary
Medline Industries, LP is recalling approximately 270,311 units of Medline Convenience Kits containing select SKUs of 10mL polycarbonate colored syringes. The affected products include the Eye Pack (DYNJ35056A) and Heart Cath Pack (DYNJ69318A) distributed nationwide in the US and to Canada, Panama, and Barbados.
The recall was initiated because unapproved design changes were made to the products outside of the FDA 510(k) clearance. This means the syringes were modified in ways that had not been reviewed and approved by the FDA prior to distribution.
Specific lot numbers for the affected products are identified in the FDA recall notice. Healthcare facilities and providers that received these syringes should stop use and contact Medline Industries for instructions on product return or replacement. Consumers who have received these products should consult their healthcare provider for guidance.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
- Manufacturer
- Medline Industries, LP
- Affected units
- 270,311
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 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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