🏥 Medical Devices • 6,839 recalls
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
CareFusion 303
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Arrow International
Product lidstock contains the incorrect expiration date for the product
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Arrow International
Product lidstock contains the incorrect expiration date for the product
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Arrow International
Product lidstock contains the incorrect expiration date for the product
Arrow International
Product lidstock contains the incorrect expiration date for the product
Arrow International
Product lidstock contains the incorrect expiration date for the product
The product do not meet certain internal testing specifications.