"Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction
Recall
- Recall Number
- Z-2292-2017
- Event Number
- 76937
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- FOZ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- March 20, 2017
- Terminated
- December 18, 2018
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
"Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the central catheters to the desired location which is the lower third of the SVC or at the cavo-atrial junction
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Arrow International sent an Urgent Medical Device Notification Letter dated April 5, 2017, to affected customers to inform them of the issue. The notice provided safety instructions for using the product and instructed customers to return the enclosed acknowledgement form indicating the notice was received, and fax it to 855-419-8507, Attn: Customer Service or email to [email protected]. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Nationwide Distribution
unknown-firm reports total devices distributed 43,394