Recall Z-1036-2008 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
B. Braun Medical, Inc.
Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109
| Date | May 7, 2008 (initiated Dec 10, 2007) |
| Status | Terminated |
| Reason | Faulty tubing does not prime machine as intended. |
| Root cause | Process control |
| Action | B. Braun Medical sent an Urgent Medical Device Reall letter dated 12/12/07. Customers were told to discontinue use of the tubing. |
| Quantity | 956 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952631 | BRAUN HEMODIALYSIS BLOOD CIRCUITS B.Braun Medical, Inc., Apr 30, 1996 |