Class I - Dangerous
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Class I - Dangerous
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
Pharmaceutical Innovations
Class I - Dangerous
Potential for failed stability antimicrobial effectiveness testing.
The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
Class I - Dangerous
Potential for the polyaxial screw to become disassembled during implant.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Datascope
Class I - Dangerous
Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
Pharmaceutical Innovations
Class I - Dangerous
Potential for failed stability antimicrobial effectiveness testing.
Class I - Dangerous
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Class I - Dangerous
The products do not have sufficient data to support the labeled shelf life of 10 years.
Class I - Dangerous
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
Pharmaceutical Innovations
Class I - Dangerous
Potential for failed stability antimicrobial effectiveness testing.
The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).
Class I - Dangerous
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.