8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
COVIDIEN
🏥 Medical Devices Class I - Dangerous
The product was released into commercial distribution while subject to importation refusal.
All Recalls
95,064 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
🏥 Medical Devices Class I - Dangerous
Table may drift in the roll position while in use
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Fresenius Medical Care Renal Therapies Group
🏥 Medical Devices Class I - Dangerous
Potential for external blood leaks from the dialyzer header
Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the Dimension Vista instrument may continue to deliver the cancelled sample or vial contents to the aliquot well(s). Future samples may be assigned to the same aliquot well(s) and become contaminated with the existing contents or overflow of the aliquot well may occur potentially contaminating a surrounding well(s). This issue only occurs when an operator manually cancels a test(s) for calibration, quality control (QC) or patient sample while the instrument is in the process of aliquotting the sample.
🏥 Medical Devices Class I - Dangerous
Screw is missing from the package
🏥 Medical Devices Class I - Dangerous
The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received three (3) complaints related to this issue with no serious injuries reported.
RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
🏥 Medical Devices Class I - Dangerous
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
🏥 Medical Devices Class I - Dangerous
Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
🏥 Medical Devices Class I - Dangerous
lack of 510K
🏥 Medical Devices Class I - Dangerous
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
🏥 Medical Devices Class I - Dangerous
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
🏥 Medical Devices Class I - Dangerous
lack of 510K
🏥 Medical Devices Class I - Dangerous
Table may drift in the roll position while in use
🏥 Medical Devices Class I - Dangerous
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
🏥 Medical Devices Class I - Dangerous
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.