Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leaks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leakage of gastric contents) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 39 units of the EndoVive 3s Low Profile Balloon Kits (Part Number M00548450, Lot Number 929613). The recall is due to a leakage issue with the feeding (reflux) valve.
The feeding valve may close inconsistently or in a delayed manner when an extension set is disconnected from the device. This defect allows feeding solution or gastric contents to leak out of the device in some instances. The product is intended to provide gastric access for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients.
The affected units were distributed nationwide to Massachusetts only. Consumers and healthcare providers should stop using the affected devices and contact Xeridiem Mediem Medical Devices Inc for instructions on replacement or return.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548450 (XMD P/N 70-0050-C14) 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 End
- Manufacturer
- Xeridiem Mediem Medical Devices Inc
- Affected units
- 39
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: M00548450 (XMD P/N 70-0050-C14) Lot Number: 929613
Distribution
Part of a larger recall action
This product is one of 105 recalled by Xeridiem Mediem Medical Devices Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 105 products in this recall →Related recalls
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FDA (Devices) · 2016-03-02
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- HighXeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
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