Urine kit specimen containers recalled for non-sterile condition
Medline urine kit specimen containers labeled as sterile are actually non-sterile. This risks sample contamination, infection, 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: This is an FDA Class II recall of a risk-of-harm medical device where injury has not been reported. The hazard—non-sterile specimen containers—poses significant contamination and infection risk, but no illnesses or hospitalizations have been documented in the source.
Plain-English summary
Medline Industries is recalling 626,305 URINE KIT units (SKU DYKM1845) distributed nationwide in 13 states due to a contamination issue affecting specimen containers.
The specimen containers included in the kits are labeled as sterile but have been identified as non-sterile. Using non-sterile collection containers can result in sample contamination, leading to false results, unnecessary treatment, or prolonged hospitalization.
The affected kits have been distributed to healthcare facilities in Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. Patients and providers should stop using affected kits immediately. Healthcare facilities should verify inventory against provided lot numbers and UDI codes (Case: 40193489713993; Unit: 10193489713992).
The recalled product
- Product
- URINE KIT, SKU DYKM1845; Component No. 503581
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- contamination
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 (2)
- UDI/DI: 40193489713993 (Case)
- 10193489713992 (Ea)
Distribution
Distributed nationwide across the United States.
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