Medical Device Recall: Z-0021-2020

FDA Recalls dataset · Firm: Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan · Status: Terminated

Recall Action Class: N/A Date Initiated: 2019-05-30 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-2020.

Recall Res Number
Z-0021-2020
FEI Number
3003319165
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2019-05-30
Date Posted
2019-12-20
Date Terminated
2024-05-20
Product Code
BZD
Event Number
83318
Product Quantity
12000
Product Description Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Reason for Recall Reports of pressure relief manifold venting gas below the standard pressure.
Action Details 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.
Distribution Pattern US distribution to distributors in the states of: NC and NV.
Code Information / Serial Numbers UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)

Related Establishments / Registrations

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