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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = LOX
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