Medical device recalls Moderate risk

Cook Inc. recalls Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gas…

Recall date
October 19, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0832-2018
FDA classification
Class II
Brand / firm
Cook Inc.
Sold / distributed
US Nationwide Distribution

Why it was recalled

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

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

What was recalled

Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

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