Medical device recalls Moderate risk

Smiths Medical ASD Inc. recalls Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.

Recall date
December 9, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2759-2017
FDA classification
Class II
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
Canada only

Why it was recalled

The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.

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

What was recalled

Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.

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