Medical Device Recall: Medline Leg Bag with Undeclared Latex
Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.
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 is FDA Class II allergen mislabeling involving undeclared latex, a common allergen. No illnesses or injuries are reported in the source text, but the hazard poses significant risk of allergic reaction for sensitive users.
Plain-English summary
Medline Industries is recalling the Medline Leg bag (model REF URO12573) due to undeclared latex. The recall involves 144 devices distributed in the United States and Panama.
The leg bag is a urinary collection device. Undeclared latex poses a risk of allergic reaction for users with latex sensitivity.
Users who have a known latex allergy should discontinue use of this product. Consumers should contact their healthcare provider or Medline Industries for information about alternative devices. The firm initiated this voluntary recall.
The recalled product
- Product
- Medline Leg bag, REF URO12573
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- allergen-latex
- mis-labeling
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 (4)
- UDI/DI 20888277719290 (case)
- 10888277719293 (insert)
- Lot Numbers: 48623050001
- 48623060001
Distribution
Distribution scope not specified by the agency.
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