| Date Initiated by Firm | May 22, 2006 |
|---|
| Date Posted | June 17, 2006 |
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| Recall Status1 |
Terminated 3 on December 12, 2007 |
| Recall Number | Z-1148-06 |
|---|
| Recall Event ID |
35491 |
| 510(K)Number | K902135 |
|---|
| Product Classification |
venous access system - Product Code FOZ
|
| Product | Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit
Catalog Number: 120021 |
|---|
| Code Information |
Lot Numbers: N5M40, N6B01 |
Recalling Firm/
Manufacturer |
United States Surgical
195 McDermott Rd
North Haven CT 06473-3665
|
| For Additional Information Contact | Terrence Callahan
203-492-6273 |
|---|
Manufacturer Reason
for Recall | The 9F device may contain a 10 F sheath instead of the 9F |
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FDA Determined
Cause 2 | Other |
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| Action | United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers. |
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| Quantity in Commerce | 63 UNITS |
|---|
| Distribution | Nationwide and International
Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
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 = FOZ
|
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