Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Recall Insight

This FDA Devices action (record #Z-2137-2021) was formally reported on August 4, 2021, with the manufacturer initiating the action on June 25, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. B. Braun Medical, Inc. is listed as the recalling firm, operating out of Allentown, PA. Federal records indicate 36,144 units units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Affected products were distributed to the following US states: CA, MI, OR, and UT.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.