Z-2591-2023 Class II Ongoing
FDA device recall Z-2591-2023 was initiated by ARROW INTERNATIONAL Inc. on August 10, 2023 and is designated Class II. 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: 177 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177 units
Product Description
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term 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 Nationwide distribution.
Code Information
Batch/Lot number 13F22E0359