Z-2137-2021 Class II Terminated
FDA device recall Z-2137-2021 was initiated by B. Braun Medical, Inc. on June 25, 2021 and is designated Class II. 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 pr… The recall status is terminated (terminated October 16, 2023). Affected quantity: 36,144 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- June 25, 2021
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36,144 units
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.
Distribution Pattern
Affected products were distributed to the following US states: CA, MI, OR, and UT.
Code Information
Lot Number: 0061761278