PlainRecalls
FDA Devices Moderate Class II Terminated

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 i

Reported: July 4, 2018 Initiated: May 9, 2018 #Z-2285-2018

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
1,872
Distribution
US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.
Location
Allentown, PA

Frequently Asked Questions

What product 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.. Recalled by B. Braun Medical, Inc.. Units affected: 1,872.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2285-2018.

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