Z-1044-04

Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each...

Name: Z-1044-04 Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each...
Creator: Argon Medical Devices, Inc
Published: 2004-06-22
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2004-06-22 / Terminated / root cause: sterility

FDA source

Argon Medical Devices, Inc began a recall of Argon 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... on 2004-06-22. The reason FDA records is "Inadequate closure compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1044-04
Status: Terminated
Initiated: 2004-06-22
Posted: 2004-07-20
Terminated: 2005-11-03
Recalling firm: Argon Medical Devices, Inc
Product: Argon 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.
Product code: KDC Instrument, Surgical, Disposable
Reason for recall: Inadequate closure compromising sterility.
Root cause tag: sterility
FDA root cause: Other
Action: The recall was initiated by certified letter on 06/22/2004.
Quantity in commerce: 5604 units
Distribution: Distribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.
Product codes and lots: 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

Product code KDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)