Recall record at a glance
| Official record | Z-0943-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Breas Medical, Inc. |
| Report date | Apr 20, 2022 |
| Recall initiation date | Mar 21, 2022 |
| Quantity | 707 units |
| Location | North Billerica, MA, United States |
Official product description
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Why the product was recalled
Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity
Distribution information
US Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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