BEUDAMED
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    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

    FDA Recall
    Terminated ·Peters Surgical 42 Rue Benoit Frachon Bobigny France·Product code GAT·June 25, 2014

    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).

    FDA Recall
    Terminated ·Peters Surgical 42 Rue Benoit Frachon Bobigny France·Product code GAT·June 25, 2014

    Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·June 16, 2012

    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·August 11, 2016

    GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·May 30, 2013

    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code LRO·January 22, 2018

    Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO PACK PGYBK, V A MED CTR COLUMBIA, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VAMC-NORTHPORT, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED GU TUR BASIN SET PGYBK, V A MED CTR BAY PINES - C, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED ORTHO PACK A&B, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) CARDIOVASCULAR DRAPE, MERITCARE HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, ST. MARY'SMED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) MAJOR CYSTO TRAY, BRYAN LGH MED CENTER EAST, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) URETHRAGRAM TRAY 20/CS, NORTH MISSISSIPPI MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PELVIC EXAM TRAY, BAPTIST MEMORIAL OXFORD, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TUR PACK PGYBK 5/CS, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LABOR AND DELIVERY TRACECART (R), KEESLER MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PHASE ONE DELIVERY TRACECART, TALLAHASSEE MEM REGNL CTR-AMT, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, HOLLAND COMMUNITY HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) GU MINOR, MIDDLESEX MEMORIAL HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, ST ANTHONYS HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) T V H TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LTC/LAP TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LAP GYN TRAY, COFFEE REGIONAL MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) RADICAL PROST TRAY PGYBK, HAYS MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) D&C GYN PACK, HIGH POINTE SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CRYO TRAY PGYBK, MIDTOWN SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, HOUSTON MEDICAL CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, UNIV ARKANSAS MED LITTLE ROCK, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, In

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code LRP·February 7, 2011

    Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and T18116 (2 M). Manufactured for GEO Logistics, Copenhagen, Denmark, Made in Mexico

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·September 16, 2005

    BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code MEG·November 24, 2008

    AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017