Edwards PediaSat Oximetry Catheter Set: Potential Internal Leak Risk
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks that could affect proper device function.
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: FDA Class II recall of a medical device with potential for internal leaks (risk-of-harm product). No illnesses, injuries, or deaths have been reported. Per the severity rubric, risk-of-harm products without reported injury receive a score of 3 (High).
Plain-English summary
Edwards Lifesciences, LLC is recalling the Edwards PediaSat Oximetry Catheter Set (Model XT3515SJ, 5.5F exterior diameter, 15 cm usable length) due to a potential for internal leaks within the catheters.
The recalled product consists of 152 units across eight lot numbers (62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, 63091148). Healthcare providers and patients should verify their product's lot number against this list.
Users of this catheter set should contact Edwards Lifesciences or their healthcare provider for guidance on whether their product is affected and what actions should be taken.
The recalled product
- Product
- 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
- 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 (8)
- Lot Numbers: 62489900
- 62505764
- 62544663
- 62706301
- 62714762
- 62889054
- 62889102
- 63091148
Distribution
Distributed in 12 states:
- AZ
- CA
- FL
- IN
- MD
- MI
- NJ
- NY
- OH
- PA
- TX
- WA
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