[Recalled] Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators. — Device vented gas below the stated pressure | FDA 2019-06-14
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators. |
|---|---|
| Brand / manufacturer | TELEFLEX-MORRISVILLE |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0009-2020 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 14 June 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Device vented gas below the stated pressure.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.