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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution. Quantity: 960 units Lot/code info: UDI/DI 10889942754571 (EA), 40889942754572 (CASE), Lot Numbers: 24EBR566

UPC codes

10889942754571, 40889942754572

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.