FDA recall Z-0497-2018

Smiths Medical ASD Inc. · Class II · device

Product

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

Reason for recall

In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.

Distribution

Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland

Key facts

Status
Terminated
Initiation date
2017-08-24
Report date
2018-02-07
Termination date
2020-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2018