FDA (Devices) recall action 93731
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
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 recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.
Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.
Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.
Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.
Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.
Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.
Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.