Device recall

Z-1035-2008: Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number…

FDA device recall · Class III · B. Braun Medical, Inc.

Key facts

Recall number (Z-number) Z-1035-2008
Recall event 46348
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
Recalling firm B. Braun Medical, Inc.
Recall class Class III
Status Terminated
Termination date Oct 28, 2008
510(k) numbers K952631
FEI number 2523676

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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