Recall Z-2283-2021 ยท DQE Catheter, Oximeter, Fiber-Optic
Edwards Lifesciences, LLC
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
| Date | Jul 9, 2021 |
| Status | Terminated |
| Reason | There is a potential for internal leaks within catheters. |
| Root cause | 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 o |
| Quantity | 152 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053609 | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR Edwards Lifesciences, LLC, Feb 28, 2006 |