Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail,
FDA device recall Z-1106-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Mislabeled as to size; 10FR are labeled as 8FR.
- Action taken
- The firm hand delivered the recall notification to the consignee hospital on 6/30/04. Product at the customer have been relabeled by the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBO
- Distribution
- Missouri.
- Date initiated
- 2004-06-25
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-23
- Location
- Spencer, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERCUTANEOUS NEPHROSTOMY SET (K820867) | Van-Tec, Inc. | 1982-04-13 |