Food, drugs, devices › Breas Medical, Inc.
Device recall: Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the V
FDA enforcement event 84828 is a device recall by Breas Medical, Inc. of North Billerica, MA, initiated 28 Jan 2020 and classified Class II, with 1 product record.
FDA defines Class II as 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 15 Sep 2020. Initiation: voluntary: firm initiated. Breas Medical, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Breas Medical, Inc., North Billerica, MA.
Reason for recall
"The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover."
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1352-2020 | 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… | 629 | Class II | Terminated | 4 Mar 2020 |
Context
Other enforcement events for Breas Medical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Jul 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati | Device | Class I | 1 |
| 13 Oct 2023 | with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator devic | Device | Class II | 1 |
| 2 Jun 2022 | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who | Device | Class II | 1 |
| 21 Mar 2022 | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 | Device | Class II | 1 |
All 5 events for Breas Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Sep 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.