Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
FDA Recall #Z-0851-2019 — Class II — December 21, 2018
Product Description
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Reason for Recall
The products were manufactured with longer than specified sheaths.
Recalling Firm
Cook Inc. — Bloomington, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24
Distribution
The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Code Information
lot 8858425
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated