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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

Z-2153-2025

June 12, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 97154
Status
Ongoing
Classification
Class II
Quantity
960 units
Official record key
device-enforcement:Z-2153-2025

Official wording

Reason: 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.

Code information: UDI/DI 10889942754571 (EA), 40889942754572 (CASE), Lot Numbers: 24EBR566

Distribution pattern: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    open seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seal on its packaging. This may constitute a breach to sterility