Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Amerx Health Care
Class I - Dangerous
Not approved labeling claims (antimicrobial and autolytic debridement)
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
Fresenius Medical Care Holdings
Class I - Dangerous
Products were held at improper storage temperature
Sterility of device is not assured
Class I - Dangerous
Products were held at improper storage temperature
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
GF Health Products, Inc./d.b.a.Basic American Metal Products
Class I - Dangerous
The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended.
Class I - Dangerous
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.
The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.
Marketing without marketing clearance or approval.
Class I - Dangerous
These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows susceptible enterococci to grow appears as a falsely resistant culture. If a lab does not QC, the error would be identified as falsely resistant enterococci would have further AST workup. There could be a delay in the identification of false-resistance
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
Marketing without marketing clearance or approval.
BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.
Fresenius Medical Care Holdings
Class I - Dangerous
Products were held at improper storage temperature
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Amerx Health Care
Class I - Dangerous
Not approved labeling claims (antimicrobial and autolytic debridement)
Sterility of device is not assured
It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in malfunction. In the very unlikely case of fluid infiltration a permanent short circuit within the control panel of the Luminos dRF / Luminos dRF Max will automatically d
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
Fresenius Medical Care Holdings
Class I - Dangerous
Products were held at improper storage temperature
Class I - Dangerous
Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.