Recall Z-1352-2020 ยท NOU Continuous, Ventilator, Home Use
Breas Medical, Inc.
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 - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ven
| Date | Jan 28, 2020 |
| Status | Terminated |
| Reason | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. |
| Root cause | Device Design |
| Action | On January 28, 2020, the firm began distributing Urgent Medical Device Correction letters to affected customers. Customers were informed of the product issue and associated risk of hypercarbia caused by excessive CO2 build-up (rebreathing). Customers were instructed to do the following: " Identify users/patients who use Protective Covers (p/n 006344) with a Vivo 50 or Vivo 65 ventilators. The model of ventilator can be determined from the device label on the bottom cover. Vivo 50 units have part no 215000 and Vivo 65 units have part no 226500. " Check if the Protective Cover is used with an |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160481 | Vivo 60 Breas Medical AB, Nov 9, 2016 |