Recall Z-2176-2025— B BRAUN MEDICAL INC

Name: FDA recall Z-2176-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-09

Class I · Ongoing

Class I FDA medical device recall by B BRAUN MEDICAL INC, initiated 2025-07-09. It names one FDA 510(k) clearance: K902409. Product: Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.. Reason: 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, which is common to air eliminating filters..

Recalling firm: B BRAUN MEDICAL INC
Classification: Class I
Status: Ongoing
Initiated: 2025-07-09
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K902409 — BECTON DICKINSON 360 INFUSER (TM) SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1990-07-19

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

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

Reason for recall

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, which is common to air eliminating filters.

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