Medical Devices Recalls

Hazard: Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Hazard: An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

Hazard: Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Hazard: Users were identifying autofill failure conditions on the devices causing pump stops.

Hazard: Users were identifying autofill failure conditions on the devices causing pump stops.

Hazard: Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.

Hazard: Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.

Hazard: Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Hazard: Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Hazard: Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

Hazard: Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

Hazard: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

Hazard: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

Hazard: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

Hazard: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Hazard: There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

Hazard: Ground cable installed incorrectly.

Hazard: As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

Hazard: The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.