Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Summary
The FDA issued a Class I for Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use w by B BRAUN MEDICAL INC. Reason: Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set.
Details
Source
Device Recall
External ID
Z-2176-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Lot/Code Info: Catalog Number: V6215. Primary UDI-DI 04046964189173, Unit of Use UDI-DI: 04046964189166. Lot Number (Expiration Date): 0061742452 (30JUN2025), 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).
Quantity Affected: 34,825 units US
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-09
Company
Allentown, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B BRAUN MEDICAL INC has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B BRAUN MEDICAL INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B BRAUN MEDICAL INC have FDA actions?
B BRAUN MEDICAL INC has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2176-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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