Reported Mar 2, 2016 · Terminated
EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon…
Xeridiem Mediem Medical Devices 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: Xeridiem Mediem Medical Devices Inc · 4700 S Overland Dr · Tucson, AZ · 85714-3430
Is this the product you have?
- EndoVive 3s
- Low Profile Balloon Kits Part NumberM00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach
- Lot codes and dates
- Part NumberM00548830 (XMD
- P/N 70-0050-220) Lot Number929725
- Amount recalled
- 40
This recall covers 105 products
The agency filed one notice per product. You are reading one of them; the other 104 are below.
92 more are in the archive.
Where it was sold
- Nationwide
- MA
Why it was recalled
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
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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