FDAFDA recall Z-0193-2027 · Oct 28, 2026
B Braun Medical Inc: B Braun SAFSITE Injection Site recall
Recall found
Product
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Reason for recall
Potential for leakage and backflow at the Safsite valve.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).
- Quantity
- 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.
- Recalling firm
- B Braun Medical Inc, Bethlehem, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-14
Source: openFDA enforcement record Z-0193-2027 · search recall number Z-0193-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Nov 3, 2026, 2:31 AM EST. The agency notice is the final word.