MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B

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: 48 units Lot/code info: UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761

UPC codes

10193489431070, 40193489431071

Source

Official record: FDA (Device enforcement) ↗

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