Datascope CS300 Intra-Aortic Balloon Pump, English, 110V recall — FDA Z-1943-2019
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Complete FDA and NHTSA recall records dated in July 2019.
These records include useful source details for the selected month.
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Potential for failed stability antimicrobial effectiveness testing.
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…
Potential for the polyaxial screw to become disassembled during implant.
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and…
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)…
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences,…
Potential for failed stability antimicrobial effectiveness testing.
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
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.
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.
The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could…
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
Potential for failed stability antimicrobial effectiveness testing.
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
Lack of an adequate sterilization validation.
Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting…
The products do not have sufficient data to support the labeled shelf life of 10 years.
Potential for failed stability antimicrobial effectiveness testing.
Mold
Stuffed Mushrooms did not declare soy as a sub ingredient of Worcestershire Sauce.
Product recalled due to a concern of possible Salmonella contamination.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.