Recall Z-3179-2024 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
| Date | Sep 19, 2024 (initiated Aug 15, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | B. Braun issued Urgent Medical Device Correction letter on 8/15/24 via USPS. Letter states reason for recall, health risk and action to take: Interim Measures for User: It is recommended that users follow the additional instructions provided in Attachment 01 for connecting the patient connector to the Locksite during prograde rinseback procedures. This attachment should be posted in clinical areas where Streamline Airless System Hemodialysis Bloodlines are utilized and where they are stored until further notice. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this not |
| Quantity | 11262112 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc., Jul 18, 2008 |