FDA Medical Device Recalls (openFDA)
Edwards Lifesciences Technology SARL: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
- Recall number
- Z-0338-2007
- Recalling firm
- Edwards Lifesciences Technology SARL
- Product
- Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
- Status
- Terminated
- Initiated
- 2006-11-27
- Posted
- 2007-01-05
- Terminated
- 2012-01-23
- Reason
- Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)
- Root cause
- Other
- Action
- Edwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.
- Quantity
- 1,110 units
- Distribution
- Worldwide Distribution ----USA and countries of Columbia and Venezuela.
- Lot, serial or model codes
- Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008
- 510(k) numbers
- ["K812563"]
- PMA numbers
- not on file
- Product code
- DYG
- Firm FEI
- 2648045
- Firm city
- Anasco
- Firm state
- PR
- 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