FDA (Devices) recall action 85853
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking chemical exposure, blood loss, or infection.
Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Sets because tubing may crack or break near the Luer or Y site, risking leakage of chemicals or blood.
Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking leakage of chemicals or biohazard materials.
Becton Dickinson is recalling SafeStep Huber Needle Sets with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits due to potential tubing cracks that may cause leakage.
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of hazardous chemicals or blood.
Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking chemical exposure, blood loss, or infection.
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking leakage of chemicals or blood.
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of chemicals or biohazard materials.
Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Port Access Kits due to potential tubing cracks that may cause leakage of hazardous materials.
Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing cracks may cause leakage of chemicals or biohazard materials.
Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, risking leakage of chemicals or blood.
Becton Dickinson is recalling SafeStep Huber Needle Set Port Access Kits because tubing may crack or break, potentially causing leakage of hazardous materials or blood.