🏥 Medical Devices • 4,350 recalls
Baxter Healthcare
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
Karl Storz Endoscopy
During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.
Smiths Medical ASD
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Smiths Medical ASD
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.
DiaSorin Molecular
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
Beckman Coulter
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
ZOLL Circulation
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aesthetics Systems Usa
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
ZOLL Circulation
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.