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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2283-2021
Event ID88270
Event DescriptionEdwards 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 TypeDevices
DistributionUS: 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
Quantity152 units
Recall ReasonThere is a potential for internal leaks within catheters.
Device Classification20210818
Device Code InfoLot Numbers: 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, 63091148
Center Classification Date20210812
Recall Initiation Date20210709
Recalling FirmEdwards Lifesciences, LLC
Initial Notification Letter
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