Class 2 Device Recall Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin

• Date Initiated by Firm: June 22, 2018
• Create Date: February 15, 2019
• Recall Status: Terminated on October 05, 2020
• Recall Number: Z-0842-2019
• Recall Event ID: 80829
• 510(K)Number: K952516
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
• Code Information: Product with expiration dates between 11/30/2016 and 5/31/2020.
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• Manufacturer Reason for Recall: The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued letters via UPS tracked mail on 6/22/2018 and later again to additional customers on 7/19/2018. An amended letter was issued on 9/20/2018 via UPS tracked mail to include some model numbers that were inadvertently omitted in the previous letter issuance.
• Quantity in Commerce: Approx. 28,578,939 kits for both products
• Distribution: Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahamas, Costa Rica, Latvia, and Saudi Arabia.
• 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 = SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.