Date Initiated by Firm |
August 20, 2003 |
Date Posted |
October 15, 2003 |
Recall Status1 |
Terminated 3 on October 24, 2005 |
Recall Number |
Z-0032-04 |
Recall Event ID |
27231 |
PMA Number |
P860019 |
Product Classification |
Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
|
Product |
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151 |
Code Information |
Lot 5707453 |
Recalling Firm/ Manufacturer |
Boston Scientific Scimed One Scimed Place Maple Grove MN 55311-1566
|
For Additional Information Contact |
Michelle Gudith 763-494-1194
|
Manufacturer Reason for Recall |
Some of the recalled catheters have a component that has levels of pyrogens above specification.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them. |
Quantity in Commerce |
2 catheters |
Distribution |
The recalled products were distributed to consignees located nationwide in the United States. |
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 = LOX and Original Applicant = SCIMED LIFE SYSTEMS, INC.
|