Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid 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 and involves a medical device defect that poses a risk of harm (leakage of gastric contents), but the source text does not report any specific injuries or hospitalizations, 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 40 units of the EndoVive 3s Low Profile Balloon Kits (Part Number M00548780, Lot Number 929720). The recall was initiated due to a feeding valve leakage issue where the valve may close inconsistently or with a delay when an extension set is disconnected. This malfunction can allow feeding solution or gastric contents to leak out of the device.
The affected devices are intended to provide gastric access for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients. The recall is classified as Class II by the FDA. The source text does not specify the number of reported injuries or illnesses associated with this defect.
Consumers and healthcare providers should stop using the affected balloon kits and contact Xeridiem Mediem Medical Devices Inc for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) 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
- 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: M00548780 (XMD P/N 70-0050-D20) Lot Number: 929720
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.
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