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U.S. Department of Health and Human Services

Class 2 Device Recall Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin

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 Class 2 Device Recall Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparinsee related information
Date Initiated by FirmJune 22, 2018
Create DateFebruary 15, 2019
Recall Status1 Terminated 3 on October 05, 2020
Recall NumberZ-0843-2019
Recall Event ID 80829
510(K)NumberK952516 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductAplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. 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.
FEI Number 3012307300
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 2		Under Investigation by firm
ActionThe 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 CommerceApprox. 28,578,939 kits for both products
DistributionDistribution 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 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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