Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

Recall Insight

This FDA Devices action (record #Z-2176-2025) was formally reported on August 13, 2025, with the manufacturer initiating the action on July 9, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. B BRAUN MEDICAL INC is listed as the recalling firm, operating out of Allentown, PA. Federal records indicate 34,825 units US units are affected.

The documented reason for this recall is: Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent… Distribution data in the federal record shows the product reached: US distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WY. International distribution to Canada.. 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 1 year 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.