- Recalling firm
- B Braun Medical Inc
- Reason for recall
- Potential for leakage and backflow at the Safsite valve.
- Affected products (lot / model / serial)
- Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).
- Units affected
- 461,300 units
- 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.
- Firm location
- Bethlehem, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0193-2027
- Recall initiated
- September 14, 2026
- FDA classification date
- October 16, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99879
- Last updated on HTM Vibe
- November 3, 2026
