Recall Z-0071-04 ยท DQX Wire, Guide, Catheter
Boston Scientific
PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305
| Date | Oct 30, 2003 (initiated Sep 29, 2003) |
| Status | Terminated |
| Reason | The product has the potential to break during withdrawal process. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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/distributors, and hospitals which received the recalled product. The product was distributed by direc |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032050 | PERIVAC KIT Boston Scientific Corp, Aug 8, 2003 |