Device recall

Z-1445-06: Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos…

FDA device recall · Class II · Delphi Medical Systems

Key facts

Recall number (Z-number) Z-1445-06
Recall event 35121
Product Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
Product code FRN
Recalling firm Delphi Medical Systems
Recall class Class II
Status Terminated
Termination date Oct 16, 2006
510(k) numbers K953896
FEI number 3002794293

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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