ARROW INTERNATIONAL Inc. Recall 93014
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
ARROW INTERNATIONAL Inc. Recall 93014 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0004-2024 |
Event ID | 93014 |
Event 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 |
Product Type | Devices |
Distribution | US |
Quantity | 172 units |
Recall 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. |
Device Classification | 20231011 |
Device Code Info | Batch/Lot number 13F22G0508 |
Center Classification Date | 20231004 |
Recall Initiation Date | 20230810 |
Recalling Firm | ARROW INTERNATIONAL Inc. |
Initial Notification | Letter |
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