Space Pump IV Set — Class II medical device recall Z-2285-2018
Terminated recall by B. Braun Medical, Inc., reported 2018-07-04, distributed in CA, IL, TX. There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain
| Recall number | Z-2285-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2018-05-09 |
| Classified | 2018-06-25 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2019-12-12 |
| Distributed | CA, IL, TX |
| Countries outside the US | CA |
| Quantity | 1,872 |
| Lot numbers | 0061583973 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2285-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.