The Recall Desk
ModerateFDA (Devices)·Z-0121-2023·Announced 2022-11-02

Medline Peripheral Blood Culture Draw Kit Recall: Incorrect Expiration Dates

Medline is recalling 1,020 peripheral blood culture draw kits due to incorrect expiration dates on kit components. The CHG solution and Bactec bottle plastic have expiration dates that do not match the date listed on the kit.

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: This is an FDA Class II recall involving a labeling discrepancy where component expiration dates do not match kit labeling. No hospitalizations, injuries, or illnesses have been reported in the source material. Per the rubric, this falls under 'Minor labeling errors' which corresponds to Moderate severity.

Plain-English summary

Medline Industries, LP is recalling 1,020 Peripheral Blood Culture Draw kits (Reorder #DYNDH1561, Lot 22FMF307) used for adult blood culture collection and pre-operative skin preparation procedures.

The recall was initiated because components within the kits have expiration dates that do not match the expiration date listed on the kit's label. Specifically, the CHG solution in the Pre-Op Changing Bathing Kit and the Bactec bottle plastic both bear expiration dates that differ from the kit's labeled expiration date.

These kits were distributed in California. The affected product is identified by UDI/DI (01)40193489402811 for cases and (01)10193489402810 for individual kits.

Healthcare facilities and medical professionals who have received these kits should verify the expiration dates on all components before use. Do not use kits where component expiration dates do not match the kit's labeled date. Contact Medline Industries for instructions regarding the return or replacement of affected kits.

The recalled product

Product
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • expiration-date-error
  • 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)40193489402811 (case)
  • (01)10193489402810 (kit)
  • Lot Number 22FMF307

Distribution

Distributed nationwide across the United States.