CURAD Reusable Gel Hot/Cold Pack Contains Undisclosed Natural Rubber Latex
Medline Industries is recalling 494,273 CURAD Reusable Gel Hot/Cold Packs because the product contains natural rubber latex that is not disclosed on the label. Consumers with latex allergies face risk of allergic reaction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves allergen mislabeling for a known and serious allergen (latex). The FDA Class II classification and absence of any reported illnesses or injuries support a High severity score per the rubric criterion for allergen mislabeling without reported adverse events.
Plain-English summary
Medline Industries, LP (Northfield) is recalling 494,273 units of CURAD Reusable Gel Hot/Cold Packs due to a labeling mismatch. The product contains natural rubber latex, but this ingredient is not listed on the package label.
The failure to disclose the presence of latex creates a hazard for consumers with latex allergies, who may experience allergic reactions if exposed to the product.
The affected product was distributed in the United States and internationally to Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, and Anguilla. Consumers with latex allergies who own an affected CURAD Reusable Gel Hot/Cold Pack can identify it using the item numbers and lot codes provided by the FDA.
If you own an affected product and have a latex allergy, stop using it immediately and contact Medline Industries or your healthcare provider for guidance.
The recalled product
- Product
- CURAD REUSABLE GEL HOT/COLD PACK
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- allergen-latex
- mislabeling
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 (20)
- Item Numbers: 1) CUR959/CUR959H (Lots 69718070004
- 69718090003
- 69718100001
- 69718100004
- 69718110003
- 69719010001
- 69719030001
- 69719030004
- 69719040002
- 69719070005
- 69719080002
- 69719080006
- 69719090001
- 69719090004
- 69719100001
- 69719100004
- 69719110001
- 69719110003
- 69719110004
- 69719120001
Distribution
Distribution scope not specified by the agency.
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