Medical device recalls Moderate risk

Smiths Medical ASD Inc. recalls CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only,…

Recall date
June 5, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3071-2017
FDA classification
Class II
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
Japan, China, US

Why it was recalled

The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly.

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

What was recalled

CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.

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