—#67219

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

FDA product code: FJK — Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K952631
Affected lot / code info: Lot Number 07F06 exp 2012-05 and Lot Number 07G09 exp 2012-06

Why it was recalled

Faulty tubing does not prime machine as intended.

Root cause (FDA determination)

Process control

Action the firm took

B. Braun Medical sent an Urgent Medical Device Reall letter dated 12/12/07. Customers were told to discontinue use of the tubing.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2007-12-10
Posted by FDA: 2008-05-07
Terminated: 2008-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.