Infusomat Space Pump Administration Set Recalled for Inverted Anti-Free Flow Clip
B. Braun Medical is recalling the Infusomat Space Volumetric Pump Administration Set due to a defect where the anti-free flow clip may be inverted, potentially causing unintended medication flow. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a potential design defect (inverted anti-free flow clip) that could result in unintended medication administration. However, no injuries or illnesses have been reported, making the hazard theoretical rather than confirmed.
Plain-English summary
B. Braun Medical, Inc. is recalling 36,144 units of the Infusomat Space Volumetric Pump Administration Set, Product Code 490100 (Lot Number 0061761278). The recalled products were distributed to California, Michigan, Oregon, and Utah.
The anti-free flow clip of the administration set may be installed inverted, which could allow unintended free flow of medication if a user fails to follow the on-screen prompt to close the roller clamp prior to removing the set from the pump.
No injuries or illnesses have been reported in connection with this recall. Users of the affected lot should verify that the anti-free flow clip is properly oriented and ensure the roller clamp is closed before removing the administration set from the pump. Healthcare facilities using this product should review their inventory and take appropriate steps to identify and correct any inverted clips.
The recalled product
- Product
- Infusomat Space Volumetric Pump Administration Set, Product Code 490100
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Set
- Hazard
- free-flow
- design-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 0061761278
Distribution
Distributed in 4 states:
- CA
- MI
- OR
- UT
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