Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing solution or gastric contents to leak.
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. The hazard involves leakage of gastric contents and feeding solution, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 40 units of EndoVive 3s Low Profile Balloon Kits (Part Number M00548420, XMD P/N 70-0050-914, Lot Number 929610). The recall was initiated due to a feeding (reflux) valve leakage issue.
The defect involves the feeding valve closing inconsistently or in a delayed manner when an extension set is disconnected from the Low Profile Balloon device. This malfunction can allow feeding solution or gastric contents to leak out of the device in some instances.
The affected products were distributed nationwide to Massachusetts only. Users of these devices should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
- Manufacturer
- Xeridiem Mediem Medical Devices Inc
- Affected units
- 40
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: M00548420 (XMD P/N 70-0050-914) Lot Number: 929610
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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See all →- HighXeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
FDA (Devices) · 2016-03-02
- HighXeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
FDA (Devices) · 2016-03-02
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