Recall Z-0392-2007 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference Number 23245
| Date | Feb 1, 2007 (initiated Dec 5, 2006) |
| Status | Terminated |
| Reason | Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch |
| Root cause | Other |
| Action | On December 5, 2006, the firm began notifying all affected customers, affiliates and distributors of the recall via letter. The letter advises that the firm has voluntarily recalled specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) due to a potentially incomplete seal in the pouch. The letter advises Abbott Vascular will be replacing all returned product and that appropriate corrective actions will be implemented. |
| Quantity | 6090651 - 346 devices, 6090652 - 395 devices, 6090653 - 315 devices |
| Distribution | Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE Advanced Cardiovascular Systems, Inc., Apr 13, 1994 |