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U.S. Department of Health and Human Services

Class 2 Device Recall Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight

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 Class 2 Device Recall Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straightsee related information
Date Initiated by FirmOctober 16, 2018
Create DateNovember 05, 2019
Recall Status1 Terminated 3 on June 15, 2021
Recall NumberZ-0293-2020
Recall Event ID 83633
510(K)NumberK771701 
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
Product(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Code Information (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200 - Lot number 11230432;  (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300 - Lot numbers 11226690 and 11231581  (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301 - Lot number 11227669;  (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401 - Lot numbers 11228371 and 11230677.
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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