Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and E...
FDA Recall #Z-1028-2015 — Class III — December 17, 2014
Product Description
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).
Reason for Recall
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.
Recalling Firm
Smiths Medical ASD, Inc. — Keene, NH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
900 units
Distribution
US in the state of FL.
Code Information
Lot Number: 2782094
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated