Infusomat Space Volumetric Pump Administration Set recall
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Why was Infusomat Space Volumetric Pump Administration Set recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 0061761278
- Product
- Infusomat Space Volumetric Pump Administration Set, Product Code 490100
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 36,144 units
- Distribution
- Affected products were distributed to the following US states: CA, MI, OR, and UT.
- Recall date
- August 4, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)