Date Initiated by Firm | July 31, 2015 |
Date Posted | August 13, 2015 |
Recall Status1 |
Terminated 3 on February 05, 2016 |
Recall Number | Z-2379-2015 |
Recall Event ID |
71849 |
510(K)Number | K113363 |
Product Classification |
Catheter, embolectomy - Product Code DXE
|
Product | AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits. |
Code Information |
161905 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
|
For Additional Information Contact | Nicole Pshon 763-494-1556 |
Manufacturer 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. |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | total of 9 units |
Distribution | Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = DXE
|