FDA Enforcement
Class II
Ongoing
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
Recall: Z-3173-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3173-2024
- Event ID
- 95171
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B Braun Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- August 15, 2024
- Classification Date
- September 19, 2024
- Address
- 824 12th Ave, Bethlehem, PA, 18018-3524, United States
Description
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
Reason
Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method
Code Info
UDI-DI 04046964367762; All Unexpired Lot Numbers
Distribution
US Nationwide distribution.
Quantity
10658351 units