Recall Z-1044-04 ยท KDC Instrument, Surgical, Disposable
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.
| Date | Jul 20, 2004 (initiated Jun 22, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.