| |
Class 2 Device Recall SwanGanz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter |
 |
| Date Initiated by Firm |
February 14, 2023 |
| Date Posted |
April 12, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1380-2023 |
| Recall Event ID |
91868 |
| Product Classification |
Catheter, flow directed - Product Code DYG
|
| Product |
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm) |
| Code Information |
Primary DI Number: 00690103146998/ Lot: 64526520
|
Recalling Firm/
Manufacturer |
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
|
| For Additional Information Contact |
linnette_torres@edwards.com
949-756-4582
|
Manufacturer Reason
for Recall |
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
|
FDA Determined
Cause 2 |
Packaging process control |
| Action |
On March 10, 2023, Edwards issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the correction, Edwards ask consignees to take the following actions:
Actions to be taken by customer
1. Review the customer letter for advice on action to be taken.
2. Please follow the instructions included in the enclosed acknowledgement form to complete the acknowledgement process.
3. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred.
4. Please post a copy of this notice near and/or with affected devices.
5. Verify your inventory on the attached acknowledgement form.
6. Contact Edwards Customer Service at 1-888-352-0904 for a Return Goods Authorization (RGA) if you would like an exchange of your device or to request a biokit if returning used devices.
Actions to be taken by distributors:
1. Please review this letter and complete the acknowledgement form. Return the acknowledgement form to US.FCA@edwards.com within 15 days of receipt of this notification. Please forward this customer communication to any of your customers who have purchased the impacted Edwards product. If you still have product within your control, please do not distribute impacted product to any customers. You can call Edwards Customer Service for instructions for handling product still within your control.
2. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product from you and Edwards will communicate directly with your customers to facilitate the correction and acknowledgement process. Please forward your customer list to US.FCA@edwards.com. If you have any questions, please contact Edwards Customer Service at: 1-888-352-0904.
Adverse Event Reporting in the US:
1. Please contact the FDA s MedWatch Adverse Event reporting program either online, by regular mail, or by fax: Complete and submit the report Onl |
| Quantity in Commerce |
326 units |
| Distribution |
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY
OUS: None |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|
