PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Mode
FDA device recall Z-0071-04 · posted 2003-10-30 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- The product has the potential to break during withdrawal process.
- Action taken
- On 9/22/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 11835 units
- Distribution
- The product was distributed worldwide to hospitals and medical supply distributors, totaling 1100 consignees. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/di
- Date initiated
- 2003-09-29
- Date posted
- 2003-10-30
- Date terminated
- 2004-03-09
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERIVAC KIT (K032050) | Boston Scientific Corp | 2003-08-08 |