ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242
FDA device recall Z-0390-2007 · posted 2007-02-01 · Terminated
Recall details
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTL
- Quantity affected
- 6090751 - 791 devices, 6090752 - 656 devices, 6091151 - 381 devices, 6091152 - 132 devices
- Distribution
- Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria.
- Date initiated
- 2006-12-05
- Date posted
- 2007-02-01
- Date terminated
- 2012-07-24
- Location
- Temecula, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE (K861847) | Advanced Cardiovascular Systems, Inc. | 1986-06-16 |
| ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES (K854261) | Advanced Cardiovascular Systems, Inc. | 1985-12-04 |