UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiop
FDA device recall Z-1237-2016 · posted 2016-03-24 · Terminated
Recall details
- Recalling firm
- Cook Inc.
- Reason for recall
- Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend AQ Ureteral Dilation Balloon Catheter Set and vice versa.
- Action taken
- Cook Medical sent an Urgent Medical Device Recall Notification letter dated January 27, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to quarantine any unused affected product. Immediately collect and return all unused affected products to Cook Medical If you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235. For questions regarding this recall call 800-457-4500.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LJE
- Quantity affected
- 20
- Distribution
- Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
- Date initiated
- 2016-01-27
- Date posted
- 2016-03-24
- Date terminated
- 2017-05-17
- Location
- Bloomington, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COOK NEPHROSTOMY DILATION BALLOON CATHETER SET (K024050) | Cook Urological, Inc. | 2003-02-27 |