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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- June 22, 2004
- Posted
- July 20, 2004
- Terminated
- November 3, 2005
- Recall Number
- Z-1044-04
- Quantity
- 5604 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Inadequate closure compromising sterility.
Distribution
Distribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.
Lot / Code Info
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
Root Cause
Other
Action Taken
The recall was initiated by certified letter on 06/22/2004.