FDAClass IIFebruary 27, 2019

Check-Flo Performer Introducer recall

Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

Why was Check-Flo Performer Introducer recalled?

The products were manufactured with longer than specified sheaths.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot 8858425

Product
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
Recalling firm
Cook Inc.
Quantity
24
Distribution
The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Recall date
February 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls