Medical equipment, implants, and diagnostic devices
Integra LifeSciences
A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
Boston Scientific
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Cincinnati Sub-Zero Products LLC, a Gentherm Company
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Karl Storz Endoscopy
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
OMNIlife science
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Fujifilm Medical Systems U.S.A.
The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
Cincinnati Sub-Zero Products LLC, a Gentherm Company
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Reversed expiration and manufacturing date on the label
B. Braun Medical
The filter capacity is not achieved due to damage of the filter membrane.
OMNIlife science
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
CareFusion 303
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
Angiodynamics
The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.
B. Braun Medical
The filter capacity is not achieved due to damage of the filter membrane.
B. Braun Medical
The filter capacity is not achieved due to damage of the filter membrane.
Heidelberg Engineering GmbH
Error in the default configuration which could lead to the incorrect display of patient master data.
The seal integrity of the sterile bag containing the kits may be compromised.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Bard Peripheral Vascular
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The seal integrity of the sterile bag containing the kits may be compromised.