| Date Initiated by Firm | March 05, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on October 26, 2005 |
| Recall Number | Z-0759-04 |
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| Recall Event ID |
28533 |
| 510(K)Number | K974640 |
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| Product Classification |
Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
|
| Product | VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston Scientific. |
|---|
| Code Information |
912502, 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 |
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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. |
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FDA Determined
Cause 2 | Other |
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| Action | Letter dated 3/5/04 with instructions to return product. |
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| Quantity in Commerce | 75 units (box/10) |
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| Distribution | 42 domestic hospitals nationwide and one distributor in Canada. |
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| 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.
|
| 510(K) Database | 510(K)s with Product Code = DRE
|
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