FDA Device recall Z-2285-2018
Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, A…
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, A… by B Braun Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2285-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-09 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | B Braun Medical |
| Distribution | CA, IL, TX |
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.
Identifiers
| code_info | Lot Number: 0061583973 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2285-2018%22
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