The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-1270
FDA device recall Z-0842-05 · posted 2005-05-13 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.
- Action taken
- The firm began notification of consignees on 3/23/2005 via certified letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 2418 UNITS
- Distribution
- Product was distributed nationwide to dealers, hospitals, sales representatives, and subsidiaries (distributors). The product was also distributed to Australia, Canada, Colombia, Czech Republic, Franc
- Date initiated
- 2005-03-18
- Date posted
- 2005-05-13
- Date terminated
- 2006-11-22
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD (K011056) | Arrow Intl., Inc. | 2001-10-24 |