BEUDAMED
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    Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK Item Number 73192 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LFJ·January 21, 2015

    Centurion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corp·Product code HFX·April 12, 2005

    Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011

    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HFX·September 8, 2014

    DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011

    Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FFX·February 23, 2009

    Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

    FDA Recall
    Terminated ·LeMaitre Vascular, Inc.·Product code KFX·March 18, 2013

    Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

    FDA Recall
    Terminated ·Surgical Design Inc·Product code HFX·January 26, 2011

    Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code HFX·August 28, 2019

    Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.

    FDA Recall
    Terminated ·Bock, Otto, Orthopedic Ind, Inc Two Carlson·Product code KFX·August 10, 2006

    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

    FDA Recall
    Terminated ·LeMaitre Vascular, Inc.·Product code KFX·March 18, 2013

    Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HFX·October 28, 2016

    Centurion brand CirClamp with 1.3 cm bell, sterile, single use; product 330.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corp·Product code HFX·April 12, 2005

    Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code HFX·August 28, 2019

    AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.

    FDA Recall
    Terminated ·Sierra Scientific Instruments Inc·Product code FFX·October 12, 2011

    Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081

    FDA Recall
    Terminated ·Medtronic Gastroenterology Urology·Product code FFX·April 28, 2004

    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code HFX·January 16, 2014

    A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HFX·September 8, 2014

    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    FDA Recall
    Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012