Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) recall — FDA Z-2199-2023
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Complete FDA and NHTSA recall records dated in July 2023.
These records include useful source details for the selected month.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was…
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery…
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the…
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the…
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery…
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.