Z-2283-2021 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
- 152 units
Product 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
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: 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, 63091148