Recall Z-2007-2020 ยท DQE Catheter, Oximeter, Fiber-Optic
Edwards Lifesciences, LLC
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
| Date | Jul 10, 2020 (initiated Mar 27, 2020) |
| Status | Terminated |
| Reason | Sterile catheter kit packaging compromised. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 597 units |
| Distribution | US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Edwards Lifescience, LLC, Feb 20, 2018 |