Edwards PediaSat Oximetry Catheter Kits Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall with a theoretical risk (potential internal leaks) where no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High (score 3).
Plain-English summary
Edwards Lifesciences, LLC is recalling Edwards PediaSat Oximetry Catheter Kits (model XT358SJ, 5.5F diameter, 8 cm usable length, 3-lumen configuration). A total of 218 units across 14 specific lot numbers are affected: 62374649, 62489899, 62505763, 62544662, 62728572, 62889053, 63045884, 63080087, 63105621, 63176482, 63256056, 63266249, 63350873, and 63374025.
The recall has been issued due to a potential for internal leaks within the catheters. These devices are intended for oximetry monitoring, and internal leaks could compromise proper device function.
The recalled devices were distributed to healthcare facilities in multiple U.S. states (California, Texas, Florida, Arizona, Pennsylvania, Indiana, New York, New Jersey, Michigan, Washington, Maryland, and Ohio) as well as internationally (Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Oman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, and Canada).
Healthcare providers and facilities in possession of these devices should cease use of affected lot numbers and contact Edwards Lifesciences for instructions regarding replacement or return.
The recalled product
- Product
- Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 218
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- LOT NUMBERS: 62374649
- 62489899
- 62505763
- 62544662
- 62728572
- 62889053
- 63045884
- 63080087
- 63105621
- 63176482
- 63256056
- 63266249
- 63350873
- 63374025
Distribution
Part of a larger recall action
This product is one of 6 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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