Device recall

Z-2663-2011: Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc…

FDA device recall · Class II · GE Healthcare, LLC

Key facts

Recall number (Z-number) Z-2663-2011
Recall event 58442
Product Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid.
Product code KZD
Recalling firm GE Healthcare, LLC
Recall class Class II
Status Terminated
Termination date Oct 31, 2012
FEI number 2126677

At a glance

  • None 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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