Clean Catch Kit specimen containers recalled for sterility labeling failure
Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.
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: FDA Class II recall with a genuine sterility labeling failure creating contamination risk. No illnesses or injuries have been reported; per the rubric, a risk-of-harm product without reported injury has a maximum score of 3 (High).
Plain-English summary
Medline Industries is recalling 626,305 Clean Catch Kit units (SKU DYKM1833A) distributed nationwide. The specimen containers included in these kits are labeled as sterile but have been found to be non-sterile.
The non-sterile containers create a risk of specimen contamination. Patients using these kits may unknowingly provide contaminated samples for medical testing, potentially leading to unnecessary treatment or prolonged hospitalization based on inaccurate test results.
The recall affects kits distributed across Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. Consumers who have these kits should contact their healthcare provider or Medline Industries for further guidance on replacement or safe handling.
The recalled product
- Product
- Clean Catch Kit, SKU DYKM1833A; Component No. 503581
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-failure
- contamination-risk
- 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 (1)
- UDI-DI: 40193489240697 (Case)
Distribution
Distributed nationwide across the United States.
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