Recalls / —

—#181054

Product

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

FDA product code

DQE — Catheter, Oximeter, Fiber-Optic

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K172423

Affected lot / code info

Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932

Why it was recalled

Sterile catheter kit packaging compromised.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Recall is to the customer level. URGENT MEDICAL DEVICE RECALL- ACTION REQUIRED letter, via FedEx, along with an acknowledgment form will be sent to all customers possessing any of the affected units. Letters will be sent overnight via FedEx. Customers will be instructed to acknowledge the notification, contact the firm at the contact information in the communication to obtain a Returned Goods Authorization (RGA) number, and to return all product to the recalling firm.

Recalling firm

Firm

Edwards Lifesciences, LLC

Address

1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern

US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.

Timeline

Recall initiated

2020-03-27

Posted by FDA

2020-07-10

Terminated

2021-04-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181054. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.