FDA recall Z-0508-2020

Product

Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

Reason for recall

There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.

Distribution

US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)

Key facts

Status

Terminated

Initiation date

2019-10-11

Report date

2019-12-11

Termination date

2023-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0508-2020