Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
This recall has been terminated (originally issued July 10, 2020).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- March 27, 2020
- Posted
- July 10, 2020
- Terminated
- April 27, 2021
- Recall Number
- Z-2007-2020
- Quantity
- 597 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterile catheter kit packaging compromised.
Distribution
US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
Lot / Code Info
Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
Root Cause
Under Investigation by firm
Action Taken
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.