Recall Z-2137-2021— B. Braun Medical, Inc.

Name: FDA recall Z-2137-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-25

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2021-06-25, terminated 2023-10-16. It names one FDA 510(k) clearance: K142036. Product: Infusomat Space Volumetric Pump Administration Set, Product Code 490100. Reason: 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-06-25
Terminated: 2023-10-16
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K142036 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETSB.Braun Medical, Inc.·cleared 2014-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.