Device recall

Z-1197-03: Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064…

FDA device recall · Class II · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-1197-03
Recall event 26731
Product Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].
Product code LZG
Recalling firm Roche Diagnostics Corp.
Recall class Class II
Status Terminated
Termination date Mar 10, 2009
510(k) numbers K023471
FEI number 1823260

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

Browse all FDA device recalls (products)