ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
FDA device recall Z-1315-04 · posted 2004-08-07 · Terminated
Recall details
- Recalling firm
- Datascope Interventional Products Division
- Reason for recall
- The motor may fail to activate when the on/off switch is pressed.
- Action taken
- Letter dated July 16, 2004 was mailed via US mail, return receipt requested.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 892
- Distribution
- The product was shipped nationwide to 243 direct accounts. and to 7 government accounts.
- Date initiated
- 2004-07-12
- Date posted
- 2004-08-07
- Date terminated
- 2004-11-22
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K031610) | Rex Medical | 2003-05-27 |