B. Braun Medical, Inc. recalls Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV…

Recall date

May 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2285-2018

FDA classification

Class II

Brand / firm

B. Braun Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.