Z-2080-2019 Class II
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- June 25, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95 units
Product Description
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
Reason for Recall
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Distribution Pattern
US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA
Code Information
REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150