RecallRadar

FDA Device recall Z-2590-2023

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

On 2023-09-27 the FDA classified a Class II recall of Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A by Arrow International, citing this recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2590-2023
ClassificationClass II
Statusongoing
Initiated2023-08-10
Published2023-09-27
Last updated2026-09-13 11:56 UTC
CompanyArrow International
DistributionUS

Product

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

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.

Identifiers

code_infoBatch/Lot number 13F22J0617

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2590-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.