Class 3 Device Recall Portex Pulsator Arterial Blood Sampling Kit

• Date Initiated by Firm: July 13, 2018
• Create Date: September 19, 2018
• Recall Status: Terminated 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.
• FEI Number: 3012307300
• 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: 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