Recall Z-1075-04 ยท MEW
Orbus Medical Technologies Inc
The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. Distributed by: E
| Date | Jul 20, 2004 (initiated Mar 19, 2004) |
| Status | Terminated |
| Reason | BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES. |
| Root cause | Other |
| Action | Orbus, the recalling firm issued a recall letter on March,19 2004 to their own label distributer, Edwards Lifesciences, requesting the return of unused product. Also Orbus provided the own label distributer with a sample sub-recall letter for them to send to users/hospital accounts. Sub-accounts were asked to return product to Edwards Lifesciences. |
| Quantity | 22 |
| Distribution | Product was shipped to one own label distributer in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023248 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies, Feb 11, 2003 |