The Recall Desk
HighFDA (Devices)·Z-2155-2025·Announced 2025-07-30

Medline Convenience Kits with BD ChloraPrep Recalled for Open Seal

Medline Convenience Kits containing BD ChloraPrep applicators are recalled for potential open seals that breach sterility and may cause patient infection. The 15,700 affected units were distributed to California, Florida, Pennsylvania, and Texas.

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 FDA Class II recall involves a packaging defect (open seal) that may breach product sterility and create risk of patient infection. No illnesses or injuries have been reported. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Medline Industries is recalling certain Medline Convenience Kits that contain BD ChloraPrep Clear - 1 mL Applicators. The recalled products are identified by three reference numbers: DYNDH1462B, DYNDH1622C, and DYNDH1866. A total of 15,700 units are affected by this recall.

The recall was initiated because the BD ChloraPrep applicators have the potential to exhibit open seals on their packaging. An open seal may breach the product's sterility guarantee. This breach in sterility may allow contamination and lead to infection-related harm for patients.

The affected kits were distributed domestically to California, Florida, Pennsylvania, and Texas. Individuals or facilities in possession of these kits should verify the lot numbers printed on their packages against the FDA recall notice. Those with affected products should contact Medline Industries for guidance.

Additional information, including specific lot numbers and product codes, is available on the FDA's recall database.

The recalled product

Product
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Blood Culture Kit
Hazard
  • seal-breach
  • infection-risk

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 (11)

  • 1) REF DYNDH1462B: UDI/DI 10195327662462 (EA)
  • 40195327662463 (CASE)
  • Lot Numbers: 24EBU164
  • 24FBD281
  • 24FBK195
  • 2) REF DYNDH1622C: UDI/DI 10195327509873 (EA)
  • 40195327509874 (CASE)
  • Lot Numbers: 24EBU004
  • 3) REF DYNDH1866: UDI/DI 10195327400958 (EA)
  • 40195327400959 (CASE)
  • Lot Numbers: 24EBT285.

Distribution

Distribution scope not specified by the agency.

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