FDA Device Recall Z-0002-2024

ARROW INTERNATIONAL Inc. · Morrisville, NC

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Lot / serial / GTIN: Batch/Lot number 33F23B0723

Quantity: 180 units

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.

Recall record

Recall number: Z-0002-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US
Recall initiated: 2023-08-10
Classified by FDA Center: 2023-10-04
FDA published: 2023-10-11
Recalling firm: ARROW INTERNATIONAL Inc.
Firm location: Morrisville, NC

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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