| |
Class 2 Device Recall PediaSat Oximetry Catheter Kit |
 |
| Date Initiated by Firm |
July 09, 2021 |
| Create Date |
August 12, 2021 |
| Recall Status1 |
Terminated 3 on January 29, 2024 |
| Recall Number |
Z-2279-2021 |
| Recall Event ID |
88270 |
| 510(K)Number |
K053609
|
| Product Classification |
Catheter, oximeter, fiber-optic - Product Code DQE
|
| Product |
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532 |
| Code Information |
LOT NUMBERS: 62685549,
62728569,
62889136,
62903838,
63256058,
62728569,
62889136,
62903838,
62939833,
62452820,
62661574,
62420335,
62889136,
63256058,
62452820,
62661574,
62685549,
62728569,
62420335,
62420335,
62452820,
62420335,
62452820,
62661574,
62889136,
62903838,
63600994,
63608318,
63608323,
62661574,
62420335,
62661574,
62903838
|
Recalling Firm/
Manufacturer |
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
|
| For Additional Information Contact |
Linnette Torres,
949-756-4582
|
Manufacturer Reason
for Recall |
There is a potential for internal leaks within catheters.
|
FDA Determined
Cause 2 |
Process control |
| Action |
On 7/9/2021 Edwards issued a "URGENT MEDICAL DEVICE PROUDCT CORRECTION" via FedEx to all affected consignees. In addition to informing consignees about the recall the firm ask consignees take the following actions:
1. The problem may be identified during preparation of the catheter for insertion per the IFU, paying specific attention to the connection between the green hub and the tubing for any signs of leakage. Additionally, the problem may be identified if when flushing the lumens of the catheter while administering a medication, a transient change of vital signs is observed.
In either of these situations, remove the catheter over a guidewire maintaining venous access and then place a new product over the venous wire. Once properly placed, remove the guidewire, and secure the catheter. New venous access is not required.
2. Please follow the instructions included in the enclosed acknowledgement form and listed below. Return the acknowledgement form to US.FCA@edwards.com.
3. There is no need to return product at this time.
4. Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred.
5. E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com within 5 days from receipt of this notification.
Product can be used as indicated above. If you have any questions, you may call Customer Service at 1-800-424-3278 option 1, from 5AM 4:30PM PST.
6. Advice on action to be taken by Distributor:
7. Please review this letter and complete the acknowledgement form. Return the acknowledgement form to US.FCA@edwards.com. Please forward this customer communication to any of your customers who have purchased the impacted Edwards PediaSat product and ask them to return the enclosed acknowledgement form.
8. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product and Edwards will communicate directly with your customers to facilit |
| Quantity in Commerce |
200 UNITS |
| Distribution |
US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL,
OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada |
| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = DQE and Original Applicant = EDWARDS LIFESCIENCES, LLC.
|
|
|
|
