EndoVive 3s Low Profile Balloon Kits recall
EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The EndoVive 3s Low Profile Balloon is intended to provide gastric…
Why was EndoVive 3s Low Profile Balloon Kits recalled?
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: M00549340 (XMD P/N 70-0050-422) Lot Number: 930141
- Product
- EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The EndoVive 3s Low Profile Balloon is intended to provide gastric…
- Recalling firm
- Xeridiem Mediem Medical Devices Inc
- Quantity
- 40
- Distribution
- Nationwide distribution to MA only.
- Recall date
- March 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)