Z-2667-2020 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; Catalog Number CPA00040 (UDI 00801741143892)
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 Number CPA00040 (UDI 00801741143892). Lot Numbers: REEN0219 REEP1376 REEP3657