AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. Fo
FDA device recall Z-2377-2015 · posted 2015-08-13 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
- Action taken
- Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 31, 2015, to all affected consignees. The letter described the problem and the affected product. Consignees were advised to segregate the affected product and return it to Boston Scientific. They were also requested consignees to complete and return the Account Reply Verification Tracking Form. Contact your Sales Representative for any questions. For questions regarding this recall call 763-494-1556.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- total of 9 units
- Distribution
- Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
- Date initiated
- 2015-07-31
- Date posted
- 2015-08-13
- Date terminated
- 2016-02-05
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS (K072769) | Possis Medical, Inc. | 2007-11-14 |