FDA-Device2019-02-27Class II

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

Cook Inc.
Hazard

The products were manufactured with longer than specified sheaths.

Sold states
The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Affected count
24
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0851-2019

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