Derived label

Device software or design

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: Unapproved design changes
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Medline Industries, LP