|
Class 3 Device Recall Thoratec |
|
Date Initiated by Firm |
December 16, 2002 |
Date Posted |
January 30, 2003 |
Recall Status1 |
Terminated 3 on August 21, 2003 |
Recall Number |
Z-0491-03 |
Recall Event ID |
25262 |
PMA Number |
P870072S012 |
Product Classification |
Ventricular (Assist) Bypass - Product Code DSQ
|
Product |
Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108
|
Code Information |
Lot Number: 17482 |
Recalling Firm/ Manufacturer |
Thoratec Corp 6035 Stoneridge Drive Pleasanton CA 94588
|
Manufacturer Reason for Recall |
The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.
|
FDA Determined Cause 2 |
Other |
Action |
On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices. |
Quantity in Commerce |
45 units |
Distribution |
The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France 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.
|
PMA Database |
PMAs with Product Code = DSQ and Original Applicant = THORATEC LABORATORIES CORP.
|
|
|
|