EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0926-2016.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0926-2016.
Recall terminated by FDA.
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- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0926-2016.
Xeridiem Mediem Medical Devices Inc
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Xeridiem Mediem Medical Devices Inc Recall FAQ
Xeridiem Mediem Medical Devices Inc is the subject of a medical devices safety report: EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to .... The notice was published on December 23, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 235 units are potentially affected.