Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.
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 a risk of harm (leakage of gastric contents) in a medical device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 38 units of the EndoVive 3s Low Profile Balloon Kits, Part Number M00549520 (XMD P/N 70-0050-824), Lot Number 930828. The devices are intended to provide gastric access for enteral feeding, medication administration, and gastric decompression in adult and pediatric patients.
The recall is due to a feeding (reflux) valve leakage issue. The valve may close inconsistently or with a delay when an extension set is disconnected, which can allow feeding solution or gastric contents to leak out of the device.
The affected units were distributed nationwide to Massachusetts only. Patients and caregivers should contact their healthcare provider or the manufacturer for instructions on how to proceed with the recall.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00549520 (XMD P/N 70-0050-824) 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
- 38
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: M00549520 (XMD P/N 70-0050-824) Lot Number: 930828
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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