Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Reported: August 4, 2021 Initiated: June 25, 2021 #Z-2137-2021
Product Description
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Reason for Recall
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.
Details
- Recalling Firm
- B. Braun Medical, Inc.
- Units Affected
- 36,144 units
- Distribution
- Affected products were distributed to the following US states: CA, MI, OR, and UT.
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
Infusomat Space Volumetric Pump Administration Set, Product Code 490100. Recalled by B. Braun Medical, Inc.. Units affected: 36,144 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2137-2021.
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