Derived label

Device software or design

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599

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