Z-0004-2024 Class I Ongoing
FDA device recall Z-0004-2024 was initiated by ARROW INTERNATIONAL Inc. on August 10, 2023 and is designated Class I. Reason for recall: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. The recall status is ongoing. Affected quantity: 172 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- August 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172 units
Product 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 for Recall
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Distribution Pattern
US
Code Information
Batch/Lot number 13F22G0508