Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the leakage of gastric contents and feeding solutions, which poses a significant risk of harm to patients.
Plain-English summary
Xeridiem Mediem Medical Devices Inc is recalling 36 units of the EndoVive 3s Low Profile Balloon Kits, Part Number M00548430 (XMD P/N 70-0050-A14), Lot Number 929611. The FDA has classified this recall as Class II. The product is intended to provide gastric access through a gastrointestinal stoma tract 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 feeding valve may close inconsistently or in a delayed manner when an extension set is disconnected from the device. This malfunction can allow feeding solution or gastric contents to leak out of the device in some instances.
The affected units were distributed nationwide to Massachusetts only. Patients and caregivers should contact their healthcare provider or the recalling firm for instructions on how to proceed with the recall.
The recalled product
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) 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…
- Manufacturer
- Xeridiem Mediem Medical Devices Inc
- Affected units
- 36
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: M00548430 (XMD P/N 70-0050-A14) Lot Number: 929611
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
Same manufacturer · Xeridiem Mediem Medical Devices Inc
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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