Microbore extension sets are labeled as having an air eliminating filter
Microbore Extension Sets with 0.2 Micron Filter are being recalled because the label indicates an air eliminating filter, but the filter fitted is not indicated for air removal. 34,825 US units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Microbore Extension Set with 0.2 Micron Filter, catalog number V6215, for use with IV tubing, primary UDI-DI 04046964189173 and unit of use UDI-DI 04046964189166, is being recalled. The action covers 34,825 units in the United States.
The stated reason is that the label is incorrect: the product label indicates that the device contains an air eliminating filter, however the filter used 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. The FDA classified the action as Class I, its most serious classification.
Distribution was to Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan and Minnesota among other states. The sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number and UDI-DI codes above and follow the instructions issued by the manufacturer.
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
- Affected units
- 34,825
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
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