Complete FDA and NHTSA recall records dated in June 2018.
These records include useful source details for the selected month.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to…
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Five warning statements are missing from the instructions for use.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux…
Five warning statements are missing from the instructions for use.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux…
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require…
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.
