SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling SafeStep Huber Needle Set myPICK Port Access Kits due to potential cracks or breaks in the tubing near the Luer or Y site. The affected products are catalog numbers CPA00020A, CPA00042A, and CPA00049, and approximately 5.3 million units have been distributed worldwide across multiple lot numbers.
When cracks or breaks develop in the tubing, leakage can occur that exposes users to chemicals such as chemotherapeutics or biohazard materials like blood. This leakage could result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination leading to infection. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution Quantity: 5,296,132 total Lot/code info: Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695). Lot Numbers: REDZ0394 REDZ1664 REDZ3037 REEN1071 REER0578 REER1113 REEN0220 REEN0271 REEN5242 REEP2688 REDZ1486 REDZ1678 REEP1382 REER1973 Additional lot added 10/16/20: REEU0318
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.