Use cautionMedical device recall · FDA · Published June 25, 2021
B. Braun Infusomat Space Volumetric Pump Recall: Anti-free flow clip may cause unintended
B. Braun recalls Infusomat Space Volumetric Pump Administration Set (Product Code 490100) due to risk of unintended fluid flow if the anti-free flow clip is inverted. Affected units sold with Lot Number 0061761278.
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
B. Braun is recalling Infusomat Space Volumetric Pump Administration Sets with Product Code 490100 because the anti-free flow clip could become inverted, causing unintended fluid flow if users don't follow on-screen prompts to close the roller clamp before removing the set from the pump. This could lead to incorrect medication delivery if not addressed. Read more at govinfonow.com/recall/62300-b-braun-infusomat-space-volumetric-pump-recall-anti-free-flow.
“B. Braun Infusomat Space Volumetric Pump Recall: Anti-free flow clip may cause unintended.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62300-b-braun-infusomat-space-volumetric-pump-recall-anti-free-flow. Based on FDA recall #Z-2137-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2021%22&limit=1).
B. Braun Medical, Inc. recalled Infusomat Space Volumetric Pump Administration Sets due to a potential for unintended free flow if the anti-free flow clip is inverted, according to the FDA. The Food and Drug Administration announced the Class II recall on June 25, 2021.
How to tell if you have it
Brand: B. Braun
Product: Infusomat Space Volumetric Pump Administration Set
Product Code: 490100
Lot Number: 0061761278
The hazard
The anti-free flow clip of the administration set may be inverted, which can cause unintended free flow if the user fails to follow on-screen prompts to close the roller clamp prior to removing the set from the pump.
Context
GovInfoNow's records show B Braun Medical Inc has issued 66 other recalls since October 15, 2013. Recent recalls include a 2026-08-19 recall of 100mL Sodium Chloride Injection for particulate matter hazards and a 2026-08-12 recall of Lactated Ringer's Injection for similar particulate matter issues. Other recent recalls of similar products include Medline Kits with B. Braun IV Sets Recalled for Check Valve Stuck Issue (2025-11-26) and Medline Neuro Angio Pack Kits Recall: Check Valve Stuck in Open or Closed Position (2025-11-26).
How to tell if you have this one
Check for the Product Code 490100 on the pump administration set. Units sold with Lot Number 0061761278 are affected. This product is used for medical infusion therapy.
Brand
B. Braun
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Inverted Clip
Inspect the anti-free flow clip to ensure it is not inverted. If inverted, close the roller clamp as instructed before removing the set from the pump.
Follow On-Screen Prompts
Always close the roller clamp before removing the set from the pump to prevent unintended fluid flow.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “Affected products were distributed to the following US states: CA, MI, OR, and UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Michigan, Oregon, Utah.
Recall timeline
FDA terminated this recall 2.3 years 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-2137-2021 (June 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2137-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.