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U.S. Department of Health and Human Services

Class 1 Device Recall Extension Set

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 Class 1 Device Recall Extension Setsee related information
Date Initiated by FirmJuly 09, 2025
Date PostedAugust 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2176-2025
Recall Event ID 97167
510(K)NumberK902409 
Product Classification Set, administration, intravascular - Product Code FPA
ProductMicrobore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Code Information 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).
Recalling Firm/
Manufacturer		 B BRAUN MEDICAL INC
861 Marcon Blvd
Allentown PA 18109-9577
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionB. 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: recalls@bbraunusa.com 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 Commerce34,825 units US
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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