FDA (Devices) recall action 95628
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Industries is recalling 626,305 urinalysis kits because the specimen containers are labeled sterile but are non-sterile, posing a risk of unnecessary treatment or hospitalization.
Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.
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.
Medline urine kit specimen containers labeled as sterile are actually non-sterile. This risks sample contamination, infection, and unnecessary treatment.
Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.
Medline Industries recalls 626,305 urine collection kits with non-sterile specimen containers labeled as sterile. The kits may cause unnecessary treatment or prolonged hospitalization.
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.
Medline Industries is recalling over 626,000 urine collection kits due to specimen containers labeled as sterile but identified as non-sterile. The defect may result in unnecessary treatment or prolonged hospitalization.