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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 144
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.
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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