Device product

Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter

Z-2591-2023

August 10, 2023

Class II

Product summary

Firm: ARROW INTERNATIONAL Inc.
Event: Event 92850
Status: Ongoing
Classification: Class II
Quantity: 177 units
Official record key: device-enforcement:Z-2591-2023

Official wording

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 information: Batch/Lot number 13F22E0359

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.