B. Braun Medical IV Extension Set Labeled with Incorrect Filter Description
B. Braun Medical is recalling 34,825 Microbore Extension Sets due to incorrect labeling claiming air-eliminating capability the device does not possess.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Regulatory guidance specifies that FDA Class I recalls must receive a severity rating of at least 4 (Severe), as the mislabeling of a critical filter capability on an IV administration device could lead to improper clinical use and patient harm.
Plain-English summary
B. Braun Medical Inc. is recalling 34,825 units of the Microbore Extension Set with 0.2 Micron Filter (Catalog Number V6215) for use with IV tubing.
The product label incorrectly indicates that the device contains an air-eliminating filter. However, the filter on this extension set is not designed for air removal and does not feature an air vent, which is a standard characteristic of air-eliminating filters. This labeling discrepancy could lead healthcare workers to rely on a safety feature the device does not actually provide.
The recalled units were distributed to 33 U.S. states and Canada. Affected lot numbers include 0061742452 through 0061936369, with expiration dates ranging from June 2025 through March 2029.
Healthcare facilities and users with affected extension sets should discontinue use and contact B. Braun Medical for replacement or disposal instructions.
The recalled product
- Product
- Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
- Manufacturer
- B BRAUN MEDICAL INC
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Catalog Number: V6215. Primary UDI-DI 04046964189173
- 0061747379 (31AUG2025 0
- 0061767411 (31JAN2026)
- 0061780914 (30APR2026)
- 0061803499 (30SEP2026)
- 0061806173 (30NOV2026)
- 0061822333 (30APR2027)
- 0061836578 (30APR2027)
- 0061849109 (31JUL2027)
- 0061850836 (31AUG2027)
- 0061899902 (30SEP2028)
- 0061936368 (31MAR2029)
- 0061936119 (31MAR2029)
- 0061936369 (31MAR2029)
- 0061940584 (30APR2029).
Distribution
Distributed in 32 states:
- 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
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