FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1036-2008
- Recalling firm
- B. Braun Medical, Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2007-12-10
- Posted
- 2008-05-07
- Terminated
- 2008-10-28
- 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.
- Lot, serial or model codes
- Lot Number 07G04 exp 2012-06
- 510(k) numbers
- ["K952631"]
- PMA numbers
- not on file
- Product code
- FJK
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28