Edwards PediaSat Oximetry Catheters Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.
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 medical device recall for a risk-of-harm product without reported injuries or hospitalizations. Internal leaks in a pediatric oximetry catheter could compromise critical monitoring, warranting a High severity rating.
Plain-English summary
Edwards Lifesciences, LLC is recalling Edwards PediaSat Oximetry Catheter Sets (REF: XT358SP) due to a potential for internal leaks within the catheters. The affected product is a 5.5F pediatric oximetry catheter with a 9 cm usable length and 3 lumens.
Internal leaks within the catheters could compromise device function during clinical use. Patients and healthcare providers who have these devices should contact Edwards Lifesciences for information about affected units.
The recall involves 178 units with affected lot numbers 62685542, 63316354, 62704123, 62667413, and 63608316. Distribution includes multiple US states (California, Texas, Florida, Arizona, Pennsylvania, Indiana, New York, New Jersey, Michigan, Washington, Maryland, Ohio) and numerous international locations.
Adverse events or injuries related to this recall should be reported to Edwards Lifesciences or to the FDA through MedWatch.
The recalled product
- Product
- Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- internal-leak
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 (6)
- Lot numbers: 62685542
- 62685542
- 63316354
- 62704123
- 62667413
- 63608316
Distribution
Distributed in 12 states:
- AZ
- CA
- FL
- IN
- MD
- MI
- NJ
- NY
- OH
- PA
- TX
- WA
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