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.
The anti-free flow clip can become inverted, which may cause the pump to release fluid unexpectedly. If users don't close the roller clamp as instructed before removing the set from the pump, unintended fluid flow could occur, potentially leading to incorrect medication delivery.
Patients using this specific pump administration set for medical infusion therapy are most at risk. Healthcare providers and caregivers who administer these pumps may also be affected.
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.
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.
Always close the roller clamp before removing the set from the pump to prevent unintended fluid flow.
Product Code 490100
Lot Number 0061761278
The anti-free flow clip may be inverted, causing unintended fluid flow if the roller clamp is not closed before removal from the pump.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-2137-2021 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-2137-2021 from B. Braun. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
