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U.S. Department of Health and Human Services

Class 3 Device Recall Portex Pulsator Arterial Blood Sampling Kit

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  Class 3 Device Recall Portex Pulsator Arterial Blood Sampling Kit see related information
Date Initiated by Firm July 13, 2018
Create Date September 19, 2018
Recall Status1 Terminated 3 on October 19, 2018
Recall Number Z-3196-2018
Recall Event ID 80632
510(K)Number K981035  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product 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.
Code Information Lot numbers 3306404, 3314069, and 3318698.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		 The product was mislabeled with the incorrect label.
FDA Determined
Cause 2		 Labeling Change Control
Action Recall notifications dated 7/13/2018 were issued via FedEx overnight mail on 7/13/2018 explaining the reason for recall, risk to health, and instructing the customer to check their inventory for the affected lot numbers.
Quantity in Commerce 29,600 kits
Distribution US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JKA and Original Applicant = SIMS PORTEX, INC.
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