Recall Z-0021-2020 ยท BZD Ventilator, Non-Continuous (Respirator)
Galemed Corporation
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
| Date | Dec 20, 2019 (initiated May 30, 2019) |
| Status | Terminated |
| Reason | Reports of pressure relief manifold venting gas below the standard pressure. |
| Root cause | Device Design |
| Action | On 05/30/2019, Medical Device Recall notices were sent to customers via email instructing them to do the following: Within 1 business day, acknowledge receipt of this recall notice. As soon as possible, within 5 business days, after this notification, notify your customers: a) That a product recall been initiated on the affected products. b) Indicate the nature of the recall. 1. Request that the affected lot codes be returned. 2. Customers who do not or cannot return affected product should be cautioned of the events which has led to this recall. 3. Within 5 business days of this notice, provi |
| Quantity | 12000 |
| Distribution | US distribution to distributors in the states of: NC and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110383 | BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 A Plus Medical, Aug 1, 2011 |