The Recall Desk
HighFDA (Devices)·Z-0311-2024·Announced 2023-11-22

Medline Peripheral Blood Culture Draw Kits Recalled Due to Expired Components

Medline is recalling 1,770 Peripheral Blood Culture Draw kits because components within the kits have expired before the kit's stated expiration date.

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 recall involves expired components in a diagnostic medical device where no illnesses or injuries have been reported. The expired components create a risk-of-harm situation through potential diagnostic failure, meeting the rubric criterion for High severity.

Plain-English summary

Medline Industries, LP is recalling 1,770 Peripheral Blood Culture Draw kits (Reference DYNDH1561) with distribution in California. The recalled kits have lot numbers 23EMF711 and 23CMH027.

The kits are being recalled because certain components within each kit have expired before the overall kit expiration date shown on the package insert. Expired components may not perform as intended for proper blood culture collection and preservation.

Healthcare facilities and providers who have received these kits should stop using them immediately. Users with questions should contact Medline Industries for further instructions.

The recalled product

Product
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
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 (3)

  • UDI/DI 40193489402811 (case)
  • 10193489402810 (unit): Lot Numbers: 23EMF711
  • 23CMH027

Distribution

Distributed nationwide across the United States.