Medline urine collection kits recalled for non-sterile specimen containers
Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.
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 medical device recall where the hazard is a concrete defect (non-sterile specimen containers labeled as sterile) with significant risk of harm. No illnesses or injuries have been reported, placing this at severity level 3 (High) per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling 626,305 urine collection kits (SKU DYLAB1016) due to a critical defect: the specimen containers are labeled as sterile but have been found to be non-sterile.
Non-sterile specimen containers present a contamination risk. According to the recall notice, potential consequences of using these non-sterile containers include unnecessary treatment and prolonged hospitalization.
The kits were distributed nationwide in 13 U.S. states: Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. Affected product lots are 22HLA350 and 22HLB291.
Consumers and healthcare providers who have these kits should stop using them immediately and contact Medline Industries for replacement products and guidance on any previously collected specimens.
The recalled product
- Product
- URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- contamination
- infection-risk
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 (3)
- UDI/DI: 40195327139941 (Case)
- 10195327139940 (Ea)
- Lots 22HLA350 22HLB291
Distribution
Distributed nationwide across the United States.
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