Medical device recalls Moderate risk

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

Recall date
December 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0851-2019
FDA classification
Class II
Brand / firm
Cook Inc.
Sold / distributed
The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.

Why it was recalled

The products were manufactured with longer than specified sheaths.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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