Medical device recalls Moderate risk

Degania Silicone, Ltd. recalls Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA…

Recall date
January 31, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1233-2017
FDA classification
Class II
Brand / firm
Degania Silicone, Ltd.
Sold / distributed
To PR only

Why it was recalled

Product sterility compromised due to breach of sterile barrier

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

What was recalled

Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.

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