Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030… recallZ-0020-2020 · Galemed Corporation · initiated May 30, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Galemed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reports of pressure relief manifold venting gas below the standard pressure.
FDA root cause category: Device Design
What the company is doing
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, provide a list of all customers contacted with product code and lot information. The recalling firm will provide information on processing of affected product. In addition, they will provide an estimated date when properly validated product will be available for shipment. Customers with additional questions were encouraged to contact the firm at [email protected]. Another recall notice, dated 09/19/19, was sent to customers and posted on the recalling firm's website (http://www.galemed.com/). Customers were asked to return reworked product.
Recall details
- Recall number
- Z-0020-2020
- Status
- Terminated
- Initiated by the company
- May 30, 2019
- Posted by the FDA
- Dec 20, 2019
- Recalling firm
- Galemed Corporation
- Quantity
- 2880
- Product code
- BZD
- FDA submissions
- K110383
- Distribution
- US distribution to distributors in the states of: NC and NV.
Product description
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Code information (models, lots, serial numbers)
UDI: 04710810093562 Lot: 180718, 181204, 190215, and 190610 (Reworked Product)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A 1030Galemed Corporation · Attachment, Breathing, Positive End Expiratory Pressure1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K110383 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Babi.Plus BC23-HDGalemed Corporation · Ventilator, Non-Continuous (Respirator)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 83318).
- Z-0021-2020 · TerminatedBabi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
- Z-0022-2020 · TerminatedBabi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page