The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the pallia
FDA device recall Z-1075-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Orbus Medical Technologies Inc
- Reason for recall
- BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEW
- Quantity affected
- 22
- Distribution
- Product was shipped to one own label distributer in California.
- Date initiated
- 2004-03-19
- Date posted
- 2004-07-20
- Date terminated
- 2012-07-08
- Location
- Fort Lauderdale, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESTENT LP SDS BILIARY ENDOPROSTHESIS (K023248) | Orbus Medical Technologies | 2003-02-11 |