BEUDAMED
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    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021

    Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·December 31, 2006

    Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·August 23, 2010

    The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock connector (e.g., Liberty cycler, Newton IQO cycler).

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code DQO·October 1, 2003

    Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir.

    FDA Recall
    Terminated ·Hospira Inc.·Product code DQO·November 2, 2004

    Catheterization Kits containing Angiographic Syringes with rotator connector.

    FDA Recall
    Terminated ·Hospira Inc.·Product code DQO·November 2, 2004

    Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-04. 6F FR6 (5-pack). Distal curve FR6. 100 cm length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQO·November 20, 2007

    Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 29, 2009

    STERIS 4085, 5085 & 5085SRT Surgical Tables

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·May 14, 2010

    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

    FDA Recall
    Terminated ·Steris Corporation·Product code FQO·June 27, 2014

    Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code FQO·September 2, 2008

    Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

    Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

    Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.

    FDA Recall
    Terminated ·Maquet Medical Systems, Usa·Product code FQO·April 13, 2012

    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FQO·September 30, 2013

    TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.

    FDA Recall
    Terminated ·Berchtold Corp.·Product code FQO·September 23, 2015

    Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Recall
    Terminated ·Cook Inc.·Product code DQO·October 7, 2015

    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FQO·June 10, 2015

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016