Reported Sep 19, 2018 · Terminated
Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
SPS Sterilization, Inc.
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: SPS Sterilization, Inc · 1110 N Gerald St · Nixa, MO · 65714-7445
Is this the product you have?
- Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
- Lot codes and dates
Code Number EZC24A-RLot Number 59634962Serial Numbers 16401032017-0116401032017-0216401032017-0316401032017-0416401032017-0516401032017-0616401032017-0716401032017-0816401032017-0916401032017-1016401032017-1116401032017-1216401032017-1316401032017-1416401032017-1516401032017-1616401032017-1716401032017-1816401032017-1916401032017-2016401032017-2116401032017-2216401032017-2316401032017-2416401032017-2516401032017-2616401032017-2716401032017-2816401032017-2916401032017-3016401032017-3116401032017-3216401032017-3316401032017-3416401032017-3516401032017-3616401032017-37
- Amount recalled
- 6 units total
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
This product could cause temporary or reversible health problems — stop using it.
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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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