Recall classifications Recalls are classified as follows: Classification Description Examples Class I Product defects are Hot/cold gel that contain a toxic substance that could potentially be ingested accidentally by a young child (Safety related) or A software error in a CT scanner that could cause the gantry cause permanent to rotate in an unintended direction and cause an injury to debilitating health or the death of a patient issues Implantable pacemakers with a defect that results in a loss of pacing output, for pacemaker-dependent patients may result in death or serious injury A false result on an IVD test for a medicine with a narrow therapeutic index that could lead to an overdose, causing permanent injury Class II Product defects could Microbial contamination of a surgical lubricant cause illness or (Safety related) A software error in a radiation treatment planning tool that mistreatment and the could lead to therapy being miscalculated and incorrectly recovery of the patient administered is likely The Instructions for Use for a catheter a precaution for certain procedures that could cause complications in its removal The incorrect combination of metal heads and liners has been supplied to surgeons. If implanted then there is a high risk of accelerated wear and tear An IVD test kit that could identify the wrong strain of and lead to inappropriate treatment Class III Product defects may A disinfectant has been mislabelled with an expiry date that not pose a significant predates the actual expiry date (Non-Safety hazard to related) The outer packaging of a consumable medical device indicates a different size to that which is actually in the
Recall classifications Recalls are classified as follows: Classification Description Examples Class I (Safety related) Product defects are potentially or cause permanent debilitating health issues Hot/cold gel that contain a toxic substance that could be ingested accidentally by a young child A software error in a CT scanner that could cause the gantry to rotate in an unintended direction and cause an injury to or the death of a patient Implantable pacemakers with a defect that results in a loss of pacing output, for pacemaker-dependent patients may result in death or serious injury A false result on an IVD test for a medicine with a narrow therapeutic index that could lead to an overdose, causing permanent injury Class II (Safety related) Product defects could cause illness or mistreatment and the recovery of the patient is likely Microbial contamination of a surgical lubricant A software error in a radiation treatment planning tool that could lead to therapy being miscalculated and incorrectly administered The Instructions for Use for a catheter a precaution for certain procedures that could cause complications in its removal The incorrect combination of metal heads and liners has been supplied to surgeons. If implanted then there is a high risk of accelerated wear and tear An IVD test kit that could identify the wrong strain of and lead to inappropriate treatment Class III (Non-Safety related) Product defects may not pose a significant hazard to A disinfectant has been mislabelled with an expiry date that predates the actual expiry date The outer packaging of a consumable medical device indicates a different size to that which is actually in the