The Recall Desk
ModerateFDA (Devices)·Z-0966-2024·Announced 2024-02-07

Medline Blood Culture Collection Kit Recalled for Undocumented Component Expiration

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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall involves a labeling discrepancy where the Bactec component expiration date is not documented on the kit insert. No illnesses or injuries have been reported, and the hazard is theoretical—users can mitigate the risk by checking the component directly. This falls within the 'minor labeling errors' criterion for a Moderate score.

Plain-English summary

Medline Industries, LP is issuing a recall for various adult blood and blood culture kits affected by this issue, including the MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B (Lot 23KBH642). The kits were distributed nationwide in the United States.

The kits involved in this recall were built using a Bactec component lot with an expiration date that was not reflected on the kit insert. This creates a documentation mismatch where users may not be aware of the component's true expiration date.

There is a risk of using an expired component if the user does not check the Bactec component inside the kit for its expiration date.

The recalled product

Product
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • mislabeling
  • expired-component

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 40195327323333 (case)
  • 10195327323332 (unit)
  • Lot Numbers: 23KBH642

Distribution

Distributed nationwide across the United States.