Recall Z-2285-2018— B. Braun Medical, Inc.

Name: FDA recall Z-2285-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-09

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2018-05-09, terminated 2019-12-12. It names one FDA 510(k) clearance: K142036. 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: 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-09
Terminated: 2019-12-12
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K142036 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETSB.Braun Medical, Inc.·cleared 2014-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.