FDA Medical Device Recalls (openFDA)
United States Surgical: Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039
- Recall number
- Z-1150-06
- Recalling firm
- United States Surgical
- Product
- Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039
- Status
- Terminated
- Initiated
- 2006-05-22
- Posted
- 2006-06-17
- Terminated
- 2007-12-12
- Reason
- The 9F device may contain a 10 F sheath instead of the 9F
- Root cause
- Other
- 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.
- Quantity
- 720 units
- Distribution
- Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec
- Lot, serial or model codes
- Lot Numbers: N5L380, N5M159, N6B02,N6B45
- 510(k) numbers
- ["K902135"]
- PMA numbers
- not on file
- Product code
- FOZ
- 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