Z-2285-2018 Class II Terminated
FDA device recall Z-2285-2018 was initiated by B. Braun Medical, Inc. on May 9, 2018 and is designated Class II. 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. The recall status is terminated (terminated Dec 12, 2019). Affected quantity: 1,872.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 4, 2018
- Initiation Date
- May 9, 2018
- Termination Date
- Dec 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,872
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.
Distribution Pattern
US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.
Code Information
Lot Number: 0061583973
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2285-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026