The Recall Desk
ModerateFDA (Devices)·Z-0964-2024·Announced 2024-02-07

Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue

Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—users may use expired components only if they fail to verify the expiration date on the component itself. This is fundamentally a labeling documentation issue without evidence of actual harm.

Plain-English summary

Medline Industries is recalling specific lots of blood culture bottle kits (Reorder Number DYNDH1738A, Lot 23JBM366) distributed nationwide in the United States. The kits contain a Bactec component whose expiration date is not reflected on the kit insert.

There is a risk that users may unknowingly use an expired component if they do not check the expiration date on the Bactec inside the kit.

The recall affects healthcare facilities and laboratories using these specific kit lots.

The recalled product

Product
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • expired-component
  • labeling-mismatch

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 40195327239849 (case)
  • 10195327239848 (unit)
  • Lot Numbers: 23JBM366

Distribution

Distributed nationwide across the United States.