Class I - Dangerous
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
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.
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.
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.