FDA recall Z-0137-2025

Product

SynchroMed II Infusion Pump. Product Number: 8637-20

Reason for recall

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

Distribution

US Nationwide distribution in the state of Mississippi.

Key facts

Status

Ongoing

Initiation date

2024-09-11

Report date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2025