Date Initiated by Firm | June 30, 2005 |
Date Posted | August 06, 2005 |
Recall Status1 |
Terminated 3 on September 14, 2010 |
Recall Number | Z-1092-05 |
Recall Event ID |
32569 |
510(K)Number | K902135 |
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
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Product | ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 9 French Introducer Kit
Catalog Number: 120021 |
Code Information |
Lot Numbers: N4G435 N4J328 N4K344 N5A181 |
Recalling Firm/ Manufacturer |
United States Surgical Corporation 195 Mcdermott Rd North Haven CT 06473-3665
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For Additional Information Contact | Lori Seferian 203-492-8167 |
Manufacturer Reason for Recall | The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use |
FDA Determined Cause 2 | Other |
Action | United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product. |
Quantity in Commerce | 527 units |
Distribution | Nationwide
Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile, |
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 = LJS
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