Medical device recalls

Smiths Medical ASD, Inc. recalls Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder N…

Recall date
December 17, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1028-2015
FDA classification
Class III
Brand / firm
Smiths Medical ASD, Inc.
Sold / distributed
US in the state of FL.

Why it was recalled

The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.

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

What was recalled

Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).

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