Z-2176-2025Class I

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

Name: Z-2176-2025 Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing
Creator: B Braun Medical Inc
Published: 2025-07-09
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2025-07-09 / Open, Classified / root cause: manufacturing process

FDA source

B BRAUN MEDICAL INC began a recall of Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing on 2025-07-09. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2176-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-09
Posted: 2025-08-06
Recalling firm: B Braun Medical Inc
Product: Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: B. Braun Medical notified consignees of the recall on about 07/09/2025 via "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 07/02/2025. The letter described the product, problem and actions to be taken. Consignees were instructed to ensure all users within your organization as well as customers, if further distributed, are notified of the recall and provided the notification letter. Review inventory and determine if any affected units are on hand, cease use and quarantine product-Do not destroy any affected product. Complete and return the Urgent Medical Device Recall Acknowledgement Form via fax to (610) 849-1197 or email to: [email protected] and arrange for the return of affected units. Once the firm receives the Acknowledgement form a customer support representative will contact you with instructions on how to return the product. For questions about this recall, please contact our BBMI's Recalls Department at 844-903-6417.
Quantity in commerce: 34,825 units US
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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2176-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2176-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-06

Product code FPA

K902409Class IIBecton Dickinson 360 Infuser (Tm) SystemBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1990-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)