The Recall Desk
ModerateFDA (Devices)·Z-0123-2023·Announced 2022-11-02

Blood Culture Collection Kit Distributed with Mismatched Component Expiration Dates

Medline is recalling 760 blood culture kits because the expiration dates printed on the kit do not match the expiration dates on the CHG Solution and Bactec bottle components inside.

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 labeling error involving expiration date mismatch on medical device components. No illnesses or injuries have been reported. The primary risk is confusion over correct component expiration dates, which healthcare facilities can address through visual inspection and inventory verification.

Plain-English summary

Medline Industries is recalling 760 Adult Blood Culture Collection Kits (Reorder #: DYNDH1632, Lot 22FMF305) distributed in California.

The kits contain components with incorrect expiration dates. Specifically, the expiration dates listed on the kit packaging do not match the expiration dates printed on the CHG Solution and Bactec bottle plastic components included in the kit.

This discrepancy creates confusion about the correct expiration date for the product components and could potentially result in the use of expired materials if the actual component date is later than the kit label. Healthcare facilities using these kits should verify the actual expiration dates on the individual components before use.

Consumers and healthcare facilities in possession of affected kits should contact Medline Industries for instructions on return or replacement.

The recalled product

Product
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • expiration-date-mismatch
  • labeling-error

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)40193489916141 (case)
  • (01)10193489916140 (kit)
  • Lot Number: 22FMF305

Distribution

Distributed nationwide across the United States.