Date Initiated by Firm | April 06, 2006 |
Date Posted | July 28, 2006 |
Recall Status1 |
Terminated 3 on August 10, 2006 |
Recall Number | Z-1305-06 |
Recall Event ID |
35280 |
Product Classification |
Embolic Protection System - Product Code NFA
|
Product | TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach. |
Code Information |
Part number 61000-01. Lot number 48275 exp 1/07 |
Recalling Firm/ Manufacturer |
Kensey Nash Corp 735 Pennsylvania Dr Exton PA 19341-1130
|
For Additional Information Contact | Robin Fatzinger 484-713-2100 |
Manufacturer Reason for Recall | Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting |
FDA Determined Cause 2 | Other |
Action | The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers. |
Quantity in Commerce | 69 kits |
Distribution | The product was shipped to hospitals in Germany and Italy. |
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.
|