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Terminated

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 Recall Z-1035-2008 · Posted 2008-05-07

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFJK
Date Initiated2007-12-10
Date Terminated2008-10-28
Product Quantity1544 units

Reason for Recall

Faulty tubing does not prime machine as intended.

Firm Action

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

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952631BRAUN HEMODIALYSIS BLOOD CIRCUITSB.Braun Medical, Inc. · 1996-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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