Device recall

Z-2206-2008: Hospira Monitoring Kit (PA Line) with 03ml Flush Device for Saginaw General…

FDA device recall · Class II · ICU Medical, Inc.

Key facts

Recall number (Z-number) Z-2206-2008
Recall event 48681
Product Hospira Monitoring Kit (PA Line) with 03ml Flush Device for Saginaw General Hosp. , Item Number: 460760451 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
Product code FMG
Recalling firm ICU Medical, Inc.
Recall class Class II
Status Terminated
Termination date Apr 13, 2010
510(k) numbers K060231
FEI number 2025816

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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