Medical device recalls Moderate risk

Cardinal Health 200, LLC recalls Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific d…

Recall date
August 1, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3107-2017
FDA classification
Class II
Brand / firm
Cardinal Health 200, LLC
Sold / distributed
Worldwide Distribution - US (Nationwide) and Internationally to Canada

Why it was recalled

The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.

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

What was recalled

Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures

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