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U.S. Department of Health and Human Services

Class 2 Device Recall Argon

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 Class 2 Device Recall Argonsee related information
Date Initiated by FirmJune 22, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall NumberZ-1044-04
Recall Event ID 29397
Product Classification Instrument, Surgical, Disposable - Product Code KDC
ProductArgon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.
Code Information Catalog Number: 001-1-110: Lot numbers.31005619, 040307981, 031105860, 040106663  Catalog Number: 001-1-320: Lot Numbers: 040308006, 040106665, 040307894, 031005622, 031105863,   Catalog Number: 001-1-120: Lot Numbers: 040106664, 040307892, 040307982,   Catalog Number: 001-1-140: Lot Number: 031065620  Catalog Number: 001-1-310: Lot Numbers: 031005621, 031105862, 040106667, 040307893, 040308005  Catalog Number: 001-1-330: Lot Numbers: 040106666, 040307895, 040308044
FEI Number 1625425
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
Manufacturer Reason
for Recall		Inadequate closure compromising sterility.
FDA Determined
Cause 2		Other
ActionThe recall was initiated by certified letter on 06/22/2004.
Quantity in Commerce5604 units
DistributionDistribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.
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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