Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and
FDA device recall Z-2190-2010 · posted 2010-08-09 · Terminated
Recall details
- Recalling firm
- Spectranetics Corporation
- Reason for recall
- Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
- Action taken
- Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 5080 units (1778 US, 3302 Non-US)
- Distribution
- Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzer
- Date initiated
- 2010-07-01
- Date posted
- 2010-08-09
- Date terminated
- 2010-08-20
- Location
- Colorado Springs, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (K073519) | Kensey Nash Corp. | 2008-03-28 |
| QUICKCAT EXTRACTION CATHETER (K060092) | Kensey Nash Corp. | 2006-03-09 |