| Date Initiated by Firm | October 05, 2006 |
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| Date Posted | March 01, 2007 |
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| Recall Status1 |
Terminated 3 on May 25, 2007 |
| Recall Number | Z-0535-2007 |
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| Recall Event ID |
36605 |
| 510(K)Number | K964518 |
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| Product Classification |
Transseptal Catheter Introducer - Product Code DYB
|
| Product | FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850. |
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| Code Information |
Lot number 1239904 |
Recalling Firm/
Manufacturer |
St. Jude Medical / Daig Division
14901 Deveau Pl
Minnetonka MN 55345-2126
|
Manufacturer Reason
for Recall | Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied. |
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FDA Determined
Cause 2 | Other |
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| Action | The affected customers were notified on 10/5/06 by letter. |
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| Quantity in Commerce | 40 Units |
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| Distribution | Nationwide. |
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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 = DYB
|
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