FDA-Device2021-08-04Class II
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
B. Braun Medical, Inc.
Hazard
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.
Sold states
Affected products were distributed to the following US states: CA, MI, OR, and UT.
Affected count
36,144 units
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief