Z-2665-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 19, 2020
- Termination Date
- July 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,296,132 total
Product Description
SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
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 Pattern
Worldwide Distribution
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