Z-0193-2027

B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068

Name: Z-0193-2027 B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068
Creator: B Braun Medical Inc
Published: 2026-09-14
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2026-09-14 / Open, Classified

FDA source

Recall record

Recall number: Z-0193-2027
Status: Open, Classified
Initiated: 2026-09-14
Posted: 2026-10-16
Recalling firm: B Braun Medical Inc
Product: B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Potential for leakage and backflow at the Safsite valve.
FDA root cause: Process control
Action: B. 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 commerce: 461,300 units
Distribution: Worldwide - 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.
Product codes and lots: Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).

Product code FPA

K942988Class IIFiltered Extension SetsB. Braun of America, Inc. / cleared 1995-07-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)