Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine
FDA device recall Z-2951-2011 · posted 2011-08-04 · Terminated
Recall details
- Recalling firm
- Spectranetics Corporation
- Reason for recall
- Packaging integrity may be compromised, thus sterility can not be assured.
- Action taken
- Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product. Further information is available at +011.49.719.447.2539.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 57 units
- Distribution
- Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.
- Date initiated
- 2011-07-18
- Date posted
- 2011-08-04
- Date terminated
- 2011-08-12
- Location
- Colorado Springs, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 (K071226) | Spectranetics Corp. | 2007-06-29 |