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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- unapproved-design-changes
Distribution
Distributed nationwide across the United States.