RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
95,075 total recalls in our database
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics Inc. (Navilyst Medical Inc.)
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.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8ยฟC, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMยฟrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Philips Electronics North America
Five warning statements are missing from the instructions for use.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8ยฟC, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMยฟrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
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.
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Zimmer Biomet
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.
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.
Philips Electronics North America
Five warning statements are missing from the instructions for use.
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The Seaberg Company
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 stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).