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U.S. Department of Health and Human Services

Class 3 Device Recall Portex Anaerobic Pulsator Arterial Blood Sampling Kit

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 Class 3 Device Recall Portex Anaerobic Pulsator Arterial Blood Sampling Kitsee related information
Date Initiated by FirmDecember 17, 2014
Date PostedJanuary 29, 2015
Recall Status1 Terminated 3 on June 25, 2015
Recall NumberZ-1028-2015
Recall Event ID 70034
510(K)NumberK952516 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductPortex 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).
Code Information Lot Number: 2782094
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact
603-352-3812
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionSmiths Medical notified American Medical Depot via telephone on 12 December 2014. Smiths Medical instructed them to put product at their location on hold. American Medical Depots customer will be instructed to return their unused product for replacement.
Quantity in Commerce900 units
DistributionUS in the state of FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JKA
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