The Recall Desk
HighFDA (Devices)·Z-0312-2024·Announced 2023-11-22

Medline Recalls Central Line Blood Culture Kits Over Expired Components

Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.

What this means for you

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: This is an FDA Class II recall of diagnostic medical device kits with expired components. The expiration defect affects a risk-of-harm product used for critical patient diagnosis (blood culture testing), and the expired materials could compromise test accuracy and performance.

Plain-English summary

Medline Industries, LP is recalling 1,600 Central Line Blood Culture DRA kits (Reference DYNDH1562) distributed nationwide in California. The recall includes kits with lot numbers 23DMF156, 23CMH030, and 23CMD955.

The recall was issued because items within the kits expired prior to the overall kit expiration date listed on the package insert. Expired components in these diagnostic kits could affect the accuracy and performance of blood culture testing, which is used to identify infections in patients.

Affected kits can be identified by UDI-DI code 40193489402446 (case level) or 10193489402445 (unit level) along with the recalled lot numbers 23DMF156, 23CMH030, and 23CMD955.

The recalled product

Product
CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • expired-components
  • quality-defect

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 (4)

  • UDI/DI 40193489402446 (case)
  • 10193489402445 (unit): Lot Numbers: 23DMF156
  • 23CMH030
  • 23CMD955

Distribution

Distributed nationwide across the United States.