Baxter Healthcare Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) recall — FDA Z-1565-2025
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code…
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Lack of sterility assurance for closed suction catheter systems
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate…
Lack of sterility assurance for closed suction catheter systems
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Label declares tahini paste but does not declare sesame.
Product tested positive for Listeria Monocytogenes.
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