BEUDAMED
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    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LTT·May 4, 2018

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MWS·August 13, 2014

    ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MWS·November 16, 2011

    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

    FDA Recall
    Terminated ·Penumbra Inc.·Product code NRY·December 15, 2020

    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

    FDA Recall
    Terminated ·Penumbra Inc.·Product code NRY·December 15, 2020

    Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

    FDA Recall
    Terminated ·Penumbra Inc.·Product code NRY·December 15, 2020

    Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

    FDA Recall
    Terminated ·Penumbra Inc.·Product code NRY·December 15, 2020

    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRS·March 31, 2021

    Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, Product ID # 730MM.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code DRS·March 31, 2021

    Flexgard, off-the-shelf knee brace, product number 14761106

    FDA Recall
    Terminated ·De Royal Industries·Product code ITQ·February 14, 2003

    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQO·April 17, 2012

    FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.

    FDA Recall
    Terminated ·Avid Medical, Inc.·Product code LRO·April 9, 2021

    High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQO·April 17, 2012

    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

    FDA Recall
    Terminated ·Avid Medical, Inc.·Product code OEZ·April 9, 2021

    Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

    FDA Recall
    Terminated ·Biomet Microfixation, LLC·Product code LZD·October 17, 2014

    Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint

    FDA Recall
    Terminated ·Biomet Microfixation, LLC·Product code LZD·October 17, 2014

    Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

    FDA Recall
    Terminated ·Biomet Microfixation, LLC·Product code LZD·October 17, 2014

    Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint

    FDA Recall
    Terminated ·Biomet Microfixation, LLC·Product code LZD·October 17, 2014

    Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code KXF·February 3, 2023