Date Initiated by Firm |
September 24, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on December 04, 2003 |
Recall Number |
Z-0085-04 |
Recall Event ID |
27491 |
510(K)Number |
K003410 K030476
|
Product Classification |
Catheter, Percutaneous - Product Code DQY
|
Product |
Concentric brand Concentric Retriever¿ X5 Percutaneous Catheter Model REF 90035 |
Code Information |
Lot numbers: 31494 or lower |
Recalling Firm/ Manufacturer |
Concentric Medical Inc 1380 Shore Bird Way Mountain View CA 94043-1338
|
For Additional Information Contact |
Matthew Shonk 651-575 Ext. 6171
|
Manufacturer Reason for Recall |
The device has the potential for tip breakage during use.
|
FDA Determined Cause 2 |
Other |
Action |
On 09/24/03, the firm issued letters and follow-up letters on 10/17/03 via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
|
Quantity in Commerce |
97 units |
Distribution |
7 consignees in the US were shipped Concentric Retriever X5 or Concentric Retriever X6 devices with lot number 31494 or lower. A total of 97 units affected were released for US distribution. Distribution was limited to 6 States: MA, GA, NY, OH, MO and CA.
The recall was appropriately extended to the user level; i.e., the hospitals which received the recalled products. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
|
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 = DQY and Original Applicant = CONCENTRIC MEDICAL, INC.
|