Recall Z-0132-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
VNUS Medical Technologies Inc
VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
| Date | Dec 15, 2007 (initiated Mar 6, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover. |
| Root cause | Package design/selection |
| Action | The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements. |
| Quantity | 92 units |
| Distribution | Nationwide: Product was distributed to 18 health care providers and medical centers throughout the US in the following states: TX, UT, CA, CT, MI, NY, MI, OR, WA, VA, PA, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 Vnus Medical Technologies, Inc., Aug 1, 2006 |