Device recall

Z-1646-2009: Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and…

FDA device recall · Class II · Disetronic Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-1646-2009
Recall event 51695
Product Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
Product code LZG
Recalling firm Disetronic Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Jun 5, 2012
510(k) numbers K060876
FEI number 1000116163

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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