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U.S. Department of Health and Human Services

Class 2 Device Recall Skater Introducer System

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 Class 2 Device Recall Skater Introducer Systemsee related information
Date Initiated by FirmApril 26, 2020
Create DateMay 22, 2020
Recall Status1 Terminated 3 on December 16, 2022
Recall NumberZ-2109-2020
Recall Event ID 85562
Product Classification Needle, catheter - Product Code GCB
ProductSkater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.
Code Information REF /LOT: 651506300/ 11267865, 11271397, 11277305, 11287825, 11293349, 11288772, 11290387, 11263199, 11262264, 11258778, 11254942, 11253443  REF/ LOT: 655506300 / 11268009, 11284776, 11266592, 11285976, 11287826, 11280359, 11260512, 11252843, 11248583, 11277295  
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information ContactMs. Rebecca Ellis
469-731-1410
Manufacturer Reason
for Recall		Tungsten coils of the guidewire included in the introducer kit were detaching.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 04/26/2020, the recalling firm sent Urgent Medical Device Recall letter by email to the affected customer/hospital/distributor. The letter will identify the product, the problem, and the action to be taken by the recipient (customer).
Quantity in Commerce15,795 units
DistributionInternational distribution to the countries of China, Taiwan.
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.
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