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

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD C

Pending LLM rewrite. Source: FDA_DEVICE Z-2155-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

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 — Devices

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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