B Braun Medical Inc Recall 95171
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
B Braun Medical Inc Recall 95171 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3173-2024 |
| Event ID | 95171 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 10658351 units |
| Recall 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 |
| Device Classification | 20240925 |
| Device Code Info | UDI-DI 04046964367762; All Unexpired Lot Numbers |
| Center Classification Date | 20240919 |
| Recall Initiation Date | 20240815 |
| Recalling Firm | B Braun Medical Inc |
| Initial Notification | Letter |
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