LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
FDA device recall Z-0995-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Lumend Inc
- Reason for recall
- Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
- Action taken
- Area Sales managers were contacted via phone conference on 05/18/04 and instructed to quarantine all outback catheters in their possession and notify all customers with any outback inventory to quarantine the product and make arrangements to retrieve the product from them.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- Quantity distributed = 122 catheters.
- Distribution
- Sent mainly to Area sales representatives.
- Date initiated
- 2004-05-18
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-26
- Location
- Redwood City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO OUTBACK CATHETER (K032298) | Lumend, Inc. | 2003-08-26 |