Medical device recalls

Smiths Medical ASD product recalled over labeling errors

Recall date
July 13, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Smiths Medical ASD Inc. recalls Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile,…
Recall number
Z-3196-2018
FDA classification
Class III
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.

Why it was recalled

The product was mislabeled with the incorrect label.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

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