Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM

FDA Recall #Z-1242-2020 — Class II — December 20, 2019

Recall #Z-1242-2020 Date: December 20, 2019 Classification: Class II Status: Terminated

Product Description

Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM

Reason for Recall

Product lidstock contains the incorrect expiration date for the product

Recalling Firm

Arrow International Inc — Reading, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

410

Distribution

Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA

Code Information

Lot Number: 13F18G0475 13F18F0729

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated