FDA Enforcement
Class I
Ongoing
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Recall: Z-0004-2024
·
Reported October 11, 2023
Enforcement
- Recall Number
- Z-0004-2024
- Event ID
- 93014
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ARROW INTERNATIONAL Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 11, 2023
- Initiation Date
- August 10, 2023
- Classification Date
- October 4, 2023
- Address
- 3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States
Description
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Reason
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Code Info
Batch/Lot number 13F22G0508
Distribution
US
Quantity
172 units