Device recall enforcement reports

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

B Braun Medical Inc · Potential for leakage and backflow at the Safsite valve.

Class IIOngoingZ-0193-2027
Status
Ongoing
City
Bethlehem
State
PA
Country
United States
Classification
Class II
Product type
Devices
Event ID
99879
Recalling firm
B Braun Medical Inc
Address 1
824 12th Ave
Postal code
18018-3524
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Recall number
Z-0193-2027
Product description
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Product quantity
461,300 units
Reason for recall
Potential for leakage and backflow at the Safsite valve.
Recall initiation date
20260914
Center classification date
20261016
Report date
20261028
Distribution pattern

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.

Code info

Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).

Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.