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Failed Dissolution Specifications
CGMP Deviations
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Defective Container
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery