Z-0001-2024 Class I Ongoing
FDA device recall Z-0001-2024 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: 1173 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
- 1173 units
Product Description
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
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 33F23B0781