FDA recall Z-2285-2018

B. Braun Medical, Inc. · Class II · device

Product

Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.

Reason for recall

There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.

Distribution

US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.

Key facts

Status
Terminated
Initiation date
2018-05-09
Report date
2018-07-04
Termination date
2019-12-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2285-2018