Unapproved design changes to the products outside of the 510(k) clearance.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ69318A lots 23FMA845 23FMA924 25BMF603
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.