Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

FDA device recall Z-0021-2020 · posted 2019-12-20 · Terminated

Recall details

Recalling firm

Galemed Corporation

Reason for recall

Reports of pressure relief manifold venting gas below the standard pressure.

Action taken

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 sales@galemed.com. 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.

Root cause

Device Design

Status

Terminated

Product code

BZD

Quantity affected

12000

Distribution

US distribution to distributors in the states of: NC and NV.

Date initiated

2019-05-30

Date posted

2019-12-20

Date terminated

2024-05-20

Location

I-Lan, Taiwan

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