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Mold contamination
Male luer in fluid administration sets may crack due to inadequate molding process
Donor tissue was released prior to information received regarding a pericardial effusion.
Component missing: Some products were issued without thermal protection switches.
Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Mislabeling: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).
Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)
Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.
Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small.
Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit
The integrity of the sterile product barrier may be compromised
A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too Small), Calibration Error Code 172 (Calibration Not Stored or Calibration Not Accepted) Controls out of range (when using a stored calibration curve).