MEDTRONIC ATS MEDICAL Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2 recall — FDA Z-0493-2021
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Complete FDA and NHTSA recall records dated in December 2020.
These records include useful source details for the selected month.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong…
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for…
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Potential Salmonella contamination.
Potential to contain undeclared egg
Potential to contain undeclared egg
Potential contamination with Salmonella.
Potential to contain undeclared egg
Fresh Express Kit Caesar Supreme bagged salad potentially contaminated with Escherichia coli STEC O26.
Recall due to presence of foreign material. Foreign object is made out of black and hard plastic.
Potential to contain undeclared egg
Potential to contain undeclared egg
Potential to contain undeclared egg
Potential to contain undeclared egg
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
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