Class 1 Device Recall Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold

• Date Initiated by Firm: May 30, 2019
• Date Posted: December 20, 2019
• Recall Status: Terminated on May 20, 2024
• Recall Number: Z-0021-2020
• Recall Event ID: 83318
• 510(K)Number: K110383
• Product Classification: Ventilator, non-continuous (respirator) - Product Code BZD
• Product: Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
• Code Information: UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)
• Recalling Firm/ Manufacturer: Galemed Corporation; 87 Wu-Jia; Li-Gong 2nd Road; I-Lan Taiwan
• Manufacturer Reason for Recall: Reports of pressure relief manifold venting gas below the standard pressure.
• FDA Determined 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 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.
• Quantity in Commerce: 12000
• Distribution: US distribution to distributors in the states of: NC and NV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BZD