Z-1035-2008

Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is...

Name: Z-1035-2008 Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is...
Creator: B. Braun Medical, Inc.
Published: 2007-12-10
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2007-12-10 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit... on 2007-12-10. The reason FDA records is "Faulty tubing does not prime machine as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1035-2008
Status: Terminated
Initiated: 2007-12-10
Posted: 2008-05-07
Terminated: 2008-10-28
Recalling firm: B Braun Medical Inc
Product: Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Faulty tubing does not prime machine as intended.
Root cause tag: manufacturing process
FDA 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 in commerce: 1544 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number 07F06 exp 2012-05 and Lot Number 07G09 exp 2012-06

Product code FJK

K952631Class IIBraun Hemodialysis Blood CircuitsB.Braun Medical, Inc. / cleared 1996-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)