Medical device recalls Moderate risk

Cook Inc. recalls Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

Recall date
May 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1780-2019
FDA classification
Class II
Brand / firm
Cook Inc.
Sold / distributed
No distribution in the US. Products were distributed to the following foreign countries: China.

Why it was recalled

The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.

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

What was recalled

Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

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