Device product

Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

Z-2590-2023

August 10, 2023

Class II

Product summary

Firm: ARROW INTERNATIONAL Inc.
Event: Event 92850
Status: Ongoing
Classification: Class II
Quantity: 190 units
Official record key: device-enforcement:Z-2590-2023

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 13F22J0617

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.