Reported Aug 18, 2021 · Terminated
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Edwards PediaSat Oximetry Catheter Set
- REF
XT358SPExterior Diameter 5.5F (1.83 mm)Usable Length 9 cm
- Number of Lumens3
- Recommended Guidewire SizeGW: 0.025" (0.64 mm), Rx Only, Sterile EO
- UDI(01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
- Lot codes and dates
- Lot numbers
62685542626855426331635462685542627041236268554262685542626674136268554262704123626855426360831662685542627041236268554262685542627041236268554262685542
- Lot numbers
- Amount recalled
- 178 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There is a potential for internal leaks within catheters.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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