SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)

Reason: 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.

Code information: 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

Distribution pattern: Worldwide Distribution