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U.S. Department of Health and Human Services

Class 2 Device Recall Argon Medical Devices AHD Luer Lock Cap

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 Class 2 Device Recall Argon Medical Devices AHD Luer Lock Capsee related information
Date Initiated by FirmOctober 16, 2018
Create DateNovember 05, 2019
Recall Status1 Terminated 3 on June 15, 2021
Recall NumberZ-0296-2020
Recall Event ID 83633
510(K)NumberK810637 
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
ProductArgon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Code Information Lot numbers 11228902 and 11230445
FEI Number 1625425
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information ContactMs. Rebecca Ellis
903-675-9321
Manufacturer Reason
for Recall		The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
FDA Determined
Cause 2		Equipment maintenance
ActionThe recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.
Quantity in CommerceTotal number in recall for all products in dist: 49,130 units
DistributionDistribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
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 = DRS
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