Z-2668-2020 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 with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
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 PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433). Lot Numbers: REEN3159 REEP3067 REEQ4064 REDS3541 REDV3438 REEN2781 REEN2145 REEP3068 REDY0835 REDZ3103