Z-2279-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- July 9, 2021
- Termination Date
- January 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 UNITS
Product Description
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
Reason for Recall
There is a potential for internal leaks within catheters.
Distribution Pattern
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
Code Information
LOT NUMBERS: 62685549, 62728569, 62889136, 62903838, 63256058, 62728569, 62889136, 62903838, 62939833, 62452820, 62661574, 62420335, 62889136, 63256058, 62452820, 62661574, 62685549, 62728569, 62420335, 62420335, 62452820, 62420335, 62452820, 62661574, 62889136, 62903838, 63600994, 63608318, 63608323, 62661574, 62420335, 62661574, 62903838