Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobi
FDA device recall Z-0338-2007 · posted 2007-01-05 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Technology SARL
- Reason for recall
- 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)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYG
- Quantity affected
- 1,110 units
- Distribution
- Worldwide Distribution ----USA and countries of Columbia and Venezuela.
- Date initiated
- 2006-11-27
- Date posted
- 2007-01-05
- Date terminated
- 2012-01-23
- Location
- Anasco, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SWAN-GANZ & EDSLAB HEPARIN COATED CATH. (K812563) | American Edwards Laboratories | 1981-09-25 |