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U.S. Department of Health and Human Services

Class 2 Device Recall RV 1000NC SAFSITE VALVE W/O EXTRA CAP

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 Class 2 Device Recall RV 1000NC SAFSITE VALVE W/O EXTRA CAPsee related information
Date Initiated by FirmSeptember 14, 2026
Date PostedOctober 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0193-2027
Recall Event ID 99879
510(K)NumberK942988 
Product Classification Set, administration, intravascular - Product Code FPA
ProductB Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Code Information Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).
FEI Number 2521402
Recalling Firm/
Manufacturer		 B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer Reason
for Recall		Potential for leakage and backflow at the Safsite valve.
FDA Determined
Cause 2		Process control
ActionB. Braun notified consignees on about 09/14/2026 via mailed "URGENT MEDICAL DEVICE REMOVAL NOTIFICATION" letter. Consignees were instructed to ensure all users within the organization are aware of the recall, notify customers if affected units were furhter distributed, review current inventory and quarantine any units on hand, and complete and return the "Urgent Medical Device Recall Acknowledgement Form" with the total number of units on hand. B. Braun Customer Support will arrange the return of affected units.
Quantity in Commerce461,300 units
DistributionWorldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand.
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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