Edwards Lifesciences, LLC Recall 88270
Description: 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
Edwards Lifesciences, LLC Recall 88270 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2283-2021 |
| Event ID | 88270 |
| Event Description | 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 |
| Product Type | Devices |
| 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 |
| Quantity | 152 units |
| Recall Reason | There is a potential for internal leaks within catheters. |
| Device Classification | 20210818 |
| Device Code Info | Lot Numbers: 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, 63091148 |
| Center Classification Date | 20210812 |
| Recall Initiation Date | 20210709 |
| Recalling Firm | Edwards Lifesciences, LLC |
| Initial Notification | Letter |
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