Use cautionMedical device recall · FDA · Published May 9, 2018
B. Braun Space Pump IV Set Recall: Risk of Wrong Filter in IV Sets
B. Braun recalls Space Pump IV sets with potential for incorrect filter that lacks air elimination. Affected units have lot number 0061583973. Consumers should check their IV sets for the filter and contact B. Braun for details.
B. Braun is recalling Space Pump IV sets that may contain a filter without air elimination. This could lead to air in the IV solution, which might cause serious health issues for patients. The recall affects specific lots of the product. Read more at govinfonow.com/recall/71158-b-braun-space-pump-iv-set-recall-risk-of-wrong.
“B. Braun Space Pump IV Set Recall: Risk of Wrong Filter in IV Sets.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71158-b-braun-space-pump-iv-set-recall-risk-of-wrong. Based on FDA recall #Z-2285-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2285-2018%22&limit=1).
The FDA announced on May 9, 2018, that B. Braun Medical, Inc. voluntarily recalled the Space Pump IV Set, Product Code 363420, due to a potential for incorrect sets without an air eliminating filter to be mixed within the lot, according to GovInfoNow's records.
How to tell if you have it
Brand: B. Braun
Product: Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter
Product Code: 363420
Lot Number: 0061583973
Quantity: 1,872 units
The hazard
The recall addresses the potential for a different set to be mixed within the lot where the incorrect set does not contain an air eliminating filter. The 0.2 Micron filter is designed to eliminate air within the IV infusion set and remove particulate matter for some medications and at-risk patient populations.
Context
GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since October 15, 2013. Recent brand recalls include a Sodium Chloride Injection recall on August 19, 2026, and a Lactated Ringer's Injection recall on August 12, 2026, both citing particulate matter hazards. Other recent recalls of similar products include Medline Kits with B. Braun IV Sets Recalled Due to Check Valve Stuck (November 26, 2025) and Medline IV Kits Recall: Check Valve Stuck in Open or Closed Position (November 26, 2025).
How to tell if you have this one
Check for the product code 363420 and lot number 0061583973 on the Space Pump IV set. The set includes two care sites with an air eliminating filter and anti-syphon valve.
Brand
B. Braun
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Your IV Set
Look for the product code 363420 and lot number 0061583973 on the Space Pump IV set.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Texas.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2285-2018 (May 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2285-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.