Beekley Bella Blanket Mammography Coverlet Recalled for Imaging Artifacts
Beekley Corporation is recalling Bella Blanket Protective Coverlets used in mammography because they can cause imaging artifacts on results.
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 hazard is limited to imaging artifacts which are a diagnostic quality issue rather than a direct physical injury or life-threatening condition, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Beekley Corporation is recalling 86,000 units of the Bella Blanket Protective Coverlet, Product Code 311, used for mammography. The product is available in 18cm x 25cm or 24cm x 30cm sizes and is designed to be placed between a patient's breast and the imaging receptor plate to reduce cold sensations. The recall affects specific lot numbers: 107657, 108150, and 108833.
The recall was initiated because the use of these coverlets can result in imaging artifacts appearing on mammogram results. This issue may interfere with the clarity of the imaging data. The affected units were distributed internationally, including nationwide in the United States, as well as in Japan and Canada.
Healthcare facilities and consumers who have these specific products should stop using them and contact Beekley Corporation for further instructions on how to return or dispose of the items.
The recalled product
- Product
- Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
- Manufacturer
- Beekley Corporation
- Hazard
- Affected units
- 86,000
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 (3)
- Lot Numbers: 107657
- 108150
- 108833
Distribution
Distributed nationwide across the United States.
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