Date Initiated by Firm |
May 20, 2005 |
Date Posted |
August 03, 2005 |
Recall Status1 |
Terminated 3 on October 03, 2006 |
Recall Number |
Z-1061-05 |
Recall Event ID |
32267 |
Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
|
Product |
Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter). |
Code Information |
Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865. |
Recalling Firm/ Manufacturer |
Maquet Inc 1140 Route 22 East Bridgewater NJ 08807-2912
|
For Additional Information Contact |
Jamie Yieh 908-947-2311
|
Manufacturer Reason for Recall |
Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.
|
FDA Determined Cause 2 |
Other |
Action |
Maquet Cardiopulmonary AG, Germany through their US firm Maquet, Inc. notified Surgemedical, Inc to return all cannula identified with the Ref. Number 22xxxx back to Maquet Cardiopulmonary. |
Quantity in Commerce |
890 units |
Distribution |
Nationwide.
Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet. |
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.
|