United States Surgical Corporation ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011
Brand
United States Surgical Corporation
Lot Codes / Batch Numbers
Lot Numbers: N4J395 N4K343
Products Sold
Lot Numbers: N4J395 N4K343
United States Surgical Corporation is recalling ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyu due to The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
Recommended Action
Per FDA guidance
United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026