FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: 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.
- Recall number
- Z-1044-04
- 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.
- Status
- Terminated
- Initiated
- 2004-06-22
- Posted
- 2004-07-20
- Terminated
- 2005-11-03
- Reason
- Inadequate closure compromising sterility.
- Root cause
- Other
- Action
- The recall was initiated by certified letter on 06/22/2004.
- Quantity
- 5604 units
- Distribution
- Distribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDC
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28