Recall Z-0995-04 ยท DQY Catheter, Percutaneous
Lumend Inc
LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
| Date | Jul 20, 2004 (initiated May 18, 2004) |
| Status | Terminated |
| Reason | Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio. |
| Root cause | Other |
| Action | 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. |
| Quantity | Quantity distributed = 122 catheters. |
| Distribution | Sent mainly to Area sales representatives. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032298 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc., Aug 26, 2003 |