UA Kit Specimen Containers Identified as Non-Sterile Despite Sterile Labeling
MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.
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: FDA Class II recall where specimen containers are non-sterile despite sterile labeling. While no illnesses have been reported, this poses a risk of sample contamination leading to diagnostic errors and potential for unnecessary treatment or prolonged hospitalization.
Plain-English summary
Medline Industries is recalling 626,305 UA Kit units (SKU DYKM1690A) distributed across the United States. The specimen containers included in these kits are labeled as sterile but have been identified to be non-sterile.
Non-sterile specimen containers pose a risk of sample contamination during collection and handling. Contaminated specimens can lead to inaccurate test results, potentially resulting in unnecessary medical treatment or prolonged hospitalization due to incorrect diagnoses.
The recalled kits were distributed nationwide to healthcare facilities in Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. The affected lot numbers are: 19KAA457, 19LAB178, 20FAB341, 20IAA286, 20WBC414, 21CBK056, 21EBG180, 21HBC490, 21KBB192, 22ABJ687, 22DBO057, 22GBO519, 22IBB016, 22LBC924, 23BBN989, 23EBF212, 23GBA753, 23IBD142, 23LBJ724, 24BBI191, 24FBC575, 24GBX259.
Healthcare facilities should identify and cease use of the affected lot numbers immediately and contact Medline Industries for replacement or quarantine procedures.
The recalled product
- Product
- UA KIT, SKU DYKM1690A; Component No. 503581
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 626,305
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: 40193489744201 (Case)
Distribution
Part of a larger recall action
This product is one of 8 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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