FDA Recalls Medline Leg Bags for Undeclared Latex
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
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 case involves undeclared latex, a common allergen, without any reported illnesses or injuries. Per FDA guidelines, allergen mislabeling without reported harm corresponds to High severity.
Plain-English summary
Medline Industries, LP has initiated a voluntary recall of Medline leg bags (REF DYND12574) due to undeclared latex. The undeclared latex may present a risk to users with latex allergies.
The recall affects 28,942 units distributed in the United States and Panama. The affected lot numbers are 48623040001, 48623050001, 48623060001, and 48623080001. Products can be identified by UDI/DI 40080196990338 (case) and 10080196990337 (insert).
The company initiated this voluntary recall on October 19, 2023. The recall remains ongoing.
The recalled product
- Product
- Medline Leg bag, REF DYND12574
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- allergen-latex
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 (6)
- UDI/DI 40080196990338 (case)
- 10080196990337 (insert)
- Lot Numbers: 48623040001
- 48623050001
- 48623060001
- 48623080001
Distribution
Distribution scope not specified by the agency.
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