Recall Z-1700-2015
Edwards Lifesciences, LLC · initiated May 5, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: lot number 59860969.
Reason for recall
The product failed to meet the internal established statistical test requirement for heparin activity.
FDA-determined cause: Process control
Action taken
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 an RGA prior to returning any unused product and return unused product to the following address: Edwards Lifesciences Return Goods/RGA # XXXXXX 1212 Alton Pkwy., Irvine, CA 92606-4838
Details
- Recall number
- Z-1700-2015
- Initiated
- May 5, 2015
- Posted by FDA
- June 2, 2015
- Terminated
- October 17, 2016
- Product code
- DYG – Catheter, Flow Directed
- Quantity
- 978
- Distribution
- Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
- Recalling firm
- Edwards Lifesciences, LLC, Irvine, CA