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EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)

FDA Recall #Z-0968-2016 — Class II — December 23, 2015

Recall #Z-0968-2016 Date: December 23, 2015 Classification: Class II Status: Terminated

Product Description

EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)

Reason for Recall

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.

Recalling Firm

Xeridiem Mediem Medical Devices Inc — Tucson, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

40

Distribution

Nationwide distribution to MA only.

Code Information

Part Number: M00548420 (XMD P/N 70-0050-914) Lot Number: 929610

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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