Z-0020-2020Class I

Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

Name: Z-0020-2020 Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Creator: Galemed Corporation
Published: 2019-05-30
License: https://open.fda.gov/license/

Galemed Corp. / initiated 2019-05-30 / Terminated / root cause: design

FDA source

Galemed Corporation began a recall of Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562 on 2019-05-30. FDA classified it as Class I and gives the reason as "Reports of pressure relief manifold venting gas below the standard pressure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0020-2020
Classification: Class I
Status: Terminated
Initiated: 2019-05-30
Posted: 2019-12-20
Terminated: 2024-05-20
Recalling firm: Galemed Corp.
Product: Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: Reports of pressure relief manifold venting gas below the standard pressure.
Root cause tag: design
FDA 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, 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.
Quantity in commerce: 2880
Distribution: US distribution to distributors in the states of: NC and NV.
Product codes and lots: UDI: 04710810093562 Lot: 180718, 181204, 190215, and 190610 (Reworked Product)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0020-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0020-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20
Z-0021-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20
Z-0022-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20

Product code BZD

K110383Class IIBabi*plus Pressure Relief Manifold - 10Cm H20, 12.5Cm H20, 15Cm H20A Plus Medical / cleared 2011-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)