Recall Z-0338-2007 ยท DYG Catheter, Flow Directed
Edwards Lifesciences Technology SARL
Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
| Date | Jan 5, 2007 (initiated Nov 27, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812563 | SWAN-GANZ & EDSLAB HEPARIN COATED CATH. American Edwards Laboratories, Sep 25, 1981 |