Medical equipment, implants, and diagnostic devices
Boston Scientific
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Medline Industries
Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
Boston Scientific
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Wright Medical Technology
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Vital Scientific N.V.
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Wright Medical Technology
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Wright Medical Technology
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Wright Medical Technology
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Abbott Gmbh & Co. KG
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Abbott GmBH & Co. KG
Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.
Abbott Gmbh & Co. KG
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Boston Scientific
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Bard Peripheral Vascular
Complaints received that products packaged with the incorrect introducer sheath size.
The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only