BEUDAMED
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    Mammomat Inspiration with Tomosynthesis functionality

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OTE·February 12, 2016

    Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code DWE·March 21, 2016

    AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code DWE·March 21, 2016

    SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·February 16, 2017

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·July 27, 2017

    MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400

    FDA Recall
    Terminated ·Maquet Inc.·Product code DWE·September 7, 2010

    Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DWE·January 30, 2014

    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·May 9, 2016

    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·October 19, 2017

    IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.

    FDA Recall
    Terminated ·International Biophysics Corp·Product code DWE·August 16, 2005

    Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWE·August 1, 2007

    Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWE·January 2, 2007

    Maquet HLM Tubing Pack; Bioline Coating

    FDA Recall
    Terminated ·Maquet Inc.·Product code DWE·July 13, 2010