FDA Medical Device Recalls (openFDA)
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 number
- Z-1091-05
- Recalling firm
- United States Surgical Corporation
- Product
- ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011
- Status
- Terminated
- Initiated
- 2005-06-30
- Posted
- 2005-08-06
- Terminated
- 2010-09-14
- Reason
- The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Root cause
- Other
- Action
- United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.
- Quantity
- 266 units
- Distribution
- Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
- Lot, serial or model codes
- Lot Numbers: N4J395 N4K343
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28