Reported Aug 18, 2021 · Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number…
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 Kit
- REF
XT3515KTPExterior Diameter 5.5F (1.83 mm)Usable Length 15 cmNumber of Lumens 3Recommended Guidewire Size 0.025" (0.64 mm)Rx OnlySterile EO
- UDI(01)00690103197563
- Lot codes and dates
- LOT NUMBERS63522902 AND 63608320
- Amount recalled
- 70 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.
Free recall alerts
Get alerted about new Edwards Lifesciences, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.