Advanced Accelerator Applications USA, Inc. has recalled 4,295 units of the NETSPOT kit, which is used to prepare Ga 68 dotatate injections. The recall was initiated because the aluminum cap crimp on the dilution buffer vial (Vial 2) may be loose. This defect could compromise the sterile seal of the vial, which is critical for patient safety during the preparation of the intravenous injection. These kits were distributed nationwide across the United States and Canada.
A loose vial cap crimp can result in a loss of container integrity, potentially leading to microbial contamination of the dilution buffer. If a contaminated buffer is used to prepare the injection, it could cause serious infections or other adverse health reactions in patients receiving the intravenous dose.
Contact healthcare provider and return product.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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