Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units p
FDA device recall Z-1036-2008 · posted 2008-05-07 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Faulty tubing does not prime machine as intended.
- Action taken
- B. Braun Medical sent an Urgent Medical Device Reall letter dated 12/12/07. Customers were told to discontinue use of the tubing.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FJK
- Quantity affected
- 956 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-12-10
- Date posted
- 2008-05-07
- Date terminated
- 2008-10-28
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAUN HEMODIALYSIS BLOOD CIRCUITS (K952631) | B.Braun Medical, Inc. | 1996-04-30 |