Date Initiated by Firm | March 05, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on October 26, 2005 |
Recall Number | Z-0760-04 |
Recall Event ID |
28533 |
Product Classification |
Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
|
Product | VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific. |
Code Information |
910482, Exp. 10/31/05 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
|
For Additional Information Contact | Nancy Cutino 508-652-5066 |
Manufacturer Reason for Recall | Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr. |
FDA Determined Cause 2 | Other |
Action | Letter dated 3/5/04 with instructions to return product. |
Quantity in Commerce | 100 units (box/10) |
Distribution | 42 domestic hospitals nationwide and one distributor in Canada. |
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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