Medical equipment, implants, and diagnostic devices
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Limacorporate S.p.A
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
RECORDATI RARE DISEASES
Out of specification stability test result for the Caphosol B solution from process validation lots
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Jewel Precision Sheet Metal & Machining Co
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Integra LifeSciences Corp. (NeuroSciences)
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Integra LifeSciences Corp. (NeuroSciences)
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Jewel Precision Sheet Metal & Machining Co
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
Integra LifeSciences Corp. (NeuroSciences)
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Limacorporate S.p.A
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.