Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0
FDA device recall Z-0555-03 · posted 2003-02-13 · Terminated
Recall details
- Recalling firm
- Cook Urological, Inc.
- Reason for recall
- Product is labeled sterile, but was not sterilized.
- Action taken
- Customers were notified by phone call and recall letter beginning on 1/22/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- EZN
- Quantity affected
- 9
- Distribution
- Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.
- Date initiated
- 2003-01-22
- Date posted
- 2003-02-13
- Date terminated
- 2003-03-26
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C (K990072) | Cook Urological, Inc. | 1999-03-25 |