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    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code LBK·January 7, 2013

    JUDKINS PACK

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code OEQ·February 11, 2021

    Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material 8886193662 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon sutures Material 8886195332J Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon sutures Material 8886196262 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures Material 8886191022 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·August 25, 2020

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSA·May 10, 2019

    UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" (2) HALSTED MOSQUITO CVD 5" SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2" X 2" 8PL Y (6) GAUZE 4" X 4" 16PL Y (1) SYRINGE 1 cc TB SffiP (1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP (1) SUTURE 3-0 BLK MONOFIL (1) TRAY ORGANIZER FULL DEEP (1) WRAPPER 30" X 30" L/F (1) PVP TRIPLE IODOPHOR SWABSTICK (1) TONGUE DEPRESSOR 6" WOOD (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP (1) SCALPEL WITH HANDLE #11 (1) MOSQUITO FORCEP STRAIGHT 5" (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) 3 PLY POLY TOWEL (1) UMBILICAL TAPE (1 ) PROBE GRONED & DISNEETNS 6" 2ML (1) EYE DRESSING EXT FINE POINT FULL (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO (1) PLASTIC TRAY 2/COMPARTMENT (1) HALF TRAY (1) STOPCOCK 3 WAY LUER SLIP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014

    GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER- C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135 STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 29, 2008

    Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.

    FDA Recall
    Terminated ·Bk Medical Mileparken 34 Iierlev Denmark·September 8, 2008

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    FDA Recall
    Terminated ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·June 28, 2016

    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.

    FDA Recall
    Terminated ·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·January 31, 2007

    Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

    Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006