Angiodynamics, Inc. is recalling 1,500 units (75 kits) of the IsoLoc Prostate Immobilization Treatment Balloon Device Kit. A single batch of these medical devices is mislabeled: the inner pouch identifies the product as an ISO-60 model with a 60cc/ml fill volume, but the actual product inside is an ISO-100 model with a 100cc/ml fill volume. This labeling error can cause clinicians to use incorrect volumes of gas or liquid during medical procedures. Consumers and healthcare facilities should contact the manufacturer regarding this mislabeled batch.
If a healthcare provider relies on the incorrect 60cc/ml label on the pouch, they may incorrectly inflate or position the 100cc/ml balloon. This could lead to improper immobilization of the prostate during treatment, potentially affecting the accuracy and effectiveness of the procedure.
Manufacturer notification and guidance
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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