Angiodynamics Recalls OARTRAC Prostate Balloon Kits Due to Accuracy Issues
Angiodynamics, Inc. is recalling 160 OARTRAC Prostate Immobilization Endorectal Balloon Device Kits because they may produce readings outside the expected accuracy range.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Angiodynamics, Inc. is recalling 160 units of the OARTRAC Prostate Immobilization Endorectal Balloon Device Kit, Catalog Number ORB-60F. The recall involves specific lot numbers 114290 and 114935, identified by UDI 00851546007066.
The recall was initiated because the devices may result in readings outside of the expected accuracy range. These pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning, permitting measurement and validation of the radiation dose received by the patient.
The affected units were distributed nationwide in the states of Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio, and Pennsylvania. The source text does not specify the actions consumers or healthcare providers should take in response to this recall.
The recalled product
- Product
- OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measur
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 114290
- 114935 UDI 00851546007066
Distribution
Part of a larger recall action
This product is one of 5 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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