Class I - Dangerous
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Class I - Dangerous
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Class I - Dangerous
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
Abbott Ireland Diagnostics Division
Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Class I - Dangerous
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Class I - Dangerous
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Class I - Dangerous
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Zevex Incorporated (dba MOOG Medical Devices Group)
Class I - Dangerous
Administration sets leaked at the filter.
Class I - Dangerous
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Class I - Dangerous
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
Zevex Incorporated (dba MOOG Medical Devices Group)
Class I - Dangerous
Administration sets leaked at the filter.
Class I - Dangerous
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
Pharmaceutical Innovations
Class I - Dangerous
Potential for failed stability antimicrobial effectiveness testing.
Class I - Dangerous
The products do not have sufficient data to support the labeled shelf life of 10 years.
Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
Pharmaceutical Innovations
Class I - Dangerous
Potential for failed stability antimicrobial effectiveness testing.
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
SpineFrontier
Class I - Dangerous
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
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.