FDA Enforcement
Class II
Ongoing
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
Recall: Z-0128-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0128-2024
- Event ID
- 93074
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B. Braun Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- September 26, 2023
- Classification Date
- November 3, 2023
- Address
- 901 Marcon Blvd, Allentown, PA, 18109-9512, United States
Description
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
Reason
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Code Info
UDI-DI: 4022495769558 Lots 0061755752, 0061761812, 0061766279
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Quantity
24,400 units