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All product recalls associated with Alpha Omega Services Inc.
Total Recalls
32
Past Year
0
Class I (Serious)
1
Most Recent
Dec 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.
Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
There is a possibility that the diameter of the catheter does not meet specifications. As a result it may not be possible to correctly connect the catheter to a VariSource Quick Connect. This would prevent any treatment. Furthermore, since the problem would not be apparent until after the catheter has been implanted an unnecessary surgical implantation procedure would have taken place.