Protective Cover Vivo 55/65 recall
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators…
Why was Protective Cover Vivo 55/65 recalled?
The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
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?
The cover does not have a lot number; these covers were distributed between 01/11/2018 and 12/17/2019
- Product
- Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators…
- Recalling firm
- Breas Medical, Inc.
- Quantity
- 629
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, FL, GA, IA, IL, KS, MA, MI, MO, NJ, NY, OH, PR, SC, TX, VA, WI and countries distribution worldwide.
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)