Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and
FDA device recall Z-2167-2013 · posted 2013-09-09 · Terminated
Recall details
- Recalling firm
- Xlumena, Inc.
- Reason for recall
- A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
- Action taken
- Xlumena sent an Urgent Medical Device Recall letter dated April 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected product. Customers with questions were instructed to contact dhasker@xlumena.com. For question regarding this recall call 650-961-9901.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 148 units
- Distribution
- Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.
- Date initiated
- 2013-04-17
- Date posted
- 2013-09-09
- Date terminated
- 2013-09-23
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVIX ACCESS DEVICE (K093279) | Xlumena | 2010-04-07 |