Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Recall
- Recall Number
- Z-0020-2020
- Event Number
- 83318
- Firm
- Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan
- FEI Number
- 3003319165
- Product Code
- BZD
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 30, 2019
- Posted
- December 20, 2019
- Terminated
- May 20, 2024
Description
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Reports of pressure relief manifold venting gas below the standard pressure.
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.
US distribution to distributors in the states of: NC and NV.
2880