Recall Z-1700-2015 ยท DYG Catheter, Flow Directed
Edwards Lifesciences, LLC
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
| Date | Jun 2, 2015 (initiated May 5, 2015) |
| Status | Terminated |
| Reason | The product failed to meet the internal established statistical test requirement for heparin activity. |
| Root cause | Process control |
| Action | On 05/05/2015 Edwards sent their consignees a letter including the following instructions: Once you have verified your inventory, please complete the attached acknowledgement form (even if you have no inventory) and fax it to Edwards Customer Service at 1-800-422-9329 within three days of receipt of this notification. This is to confirm that you have reviewed this notice and have taken appropriate action. Please call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the identified lot and obtain information about replacement product. Please call for |
| Quantity | 978 |
| Distribution | Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER Baxter Edwards, May 24, 1994 |