The Recall Desk
ModerateFDA (Devices)·Z-0120-2023·Announced 2022-11-02

Medline Blood Culture Collection Kits Recalled for Incorrect Expiration Dates

Medline recalls Adult Blood Culture Collection Kits due to incorrect expiration dates on kit components. The expiration dates on the CHG Solution and Bactec bottle plastic do not match the dates listed on the kit packaging.

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 medical device recall due to incorrect expiration date labeling on component parts with no reported illnesses or injuries. This is a labeling discrepancy that creates confusion about product expiration but poses no direct immediate health threat.

Plain-English summary

Medline Industries is recalling Adult Blood Culture Collection Kits (Reorder # DYNDH1245, Lot Number 22FMF306) that were distributed nationwide in California. The affected kits contain incorrect expiration dates on component parts. Specifically, the CHG Solution and Bactec bottle plastic have expiration dates that do not match the date listed on the kit packaging.

The mismatch between component expiration dates and the kit label creates confusion about when the kit components actually expire. Blood culture collection kits are used in healthcare settings to collect blood samples for laboratory diagnostic testing.

The FDA classified this as a Class II recall. Healthcare facilities and laboratories that have received kits from lot number 22FMF306 should identify and verify affected units in their inventory.

The recalled product

Product
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • incorrect-expiration-date
  • mislabeling

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: (01)40889942604723 (case)
  • (01)10889942604722 (kit)
  • Lot Number 22FMF306

Distribution

Distributed nationwide across the United States.