Device recall

Z-1653-2012: Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product…

FDA device recall · Class I · Pharmaceutical Innovations, Inc.

Key facts

Recall number (Z-number) Z-1653-2012
Recall event 61732
Product Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
Product code MUI
Recalling firm Pharmaceutical Innovations, Inc.
Recall class Class I
Status Terminated
Termination date Jul 19, 2021
FEI number 2241583

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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