| | Class 2 Device Recall vanSonnenberg Sump |  |
| Date Initiated by Firm | August 10, 2006 |
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| Date Posted | September 13, 2006 |
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| Recall Status1 |
Terminated 3 on February 07, 2007 |
| Recall Number | Z-1499-06 |
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| Recall Event ID |
36136 |
| 510(K)Number | K811378 |
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| Product Classification |
drain - Product Code GBW
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| Product | Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201. |
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| Code Information |
Lot 8606405; exp. March 31, 2009. |
| FEI Number |
1828132
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Recalling Firm/
Manufacturer |
Boston Scientific Corp
780 Brookside Dr
Spencer IN 47460-1080
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| For Additional Information Contact |
508-683-4678 |
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Manufacturer Reason
for Recall | Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm. |
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| Quantity in Commerce | 4 units |
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| Distribution | Texas. |
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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.
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| 510(K) Database | 510(K)s with Product Code = GBW
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