Recall Z-0709-2008 ยท HCI Applier, Aneurysm Clip
Aesculap Inc
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
| Date | Jan 29, 2008 (initiated Nov 1, 2007) |
| Status | Terminated |
| Reason | Breakage: the inner rod of the applier may corrode and break |
| Root cause | Device Design |
| Action | The recalling firm issued an Import Recall Notice, on or about December 18, 2007, to all their customers to inform them of the problem and the need to return the devices . |
| Quantity | 84 clips |
| Distribution | Worldwide- USA hospitals in AZ, CA, CO, IL, KY, MI, MS, ND, NM, NY, OH, OK, PA, TX, VA, WA, and WI, to sales representatives in NC, OK, and MO and shipped to distributors in CA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940970 | YASARGIL, CASPAR, VARIO CLIP APPLIERS Aesculap, Inc., Jan 24, 1995 |