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U.S. Department of Health and Human Services

Class 2 Device Recall Argon Medical Devices Stopcocks

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 Class 2 Device Recall Argon Medical Devices Stopcockssee related information
Date Initiated by FirmOctober 16, 2018
Create DateNovember 05, 2019
Recall Status1 Terminated 3 on June 15, 2021
Recall NumberZ-0290-2020
Recall Event ID 83633
510(K)NumberK780271 
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
Product(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx; (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.
Code Information (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A-Lot numbers 11226656 and 11228887;  (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A - Lot numbers 11226187, 11229619, and 11227967;  (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A - Lot numbers 11228888, 11230598;  (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A - Lot number 11228245;  (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A - Lot number 11232206; and  (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590 - Lot numbers 11229800 and 11232485.
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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