BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.

    FDA Recall
    Terminated ·Laborie Medical Technologies Cor·Product code EXQ·April 9, 2009

    Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code OYK·November 17, 2011

    Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FNL·May 17, 2012

    MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·April 8, 2019

    LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·April 8, 2019

    Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code HIF·February 11, 2015

    Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCJ·February 11, 2015

    Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code JCT·February 11, 2015

    Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCJ·February 11, 2015

    Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code HWE·February 11, 2015

    Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCJ·February 11, 2015

    Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCJ·February 11, 2015

    Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GCA·February 11, 2015

    Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code LIT·February 11, 2015

    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code FCP·February 11, 2015

    Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GFF·February 11, 2015

    Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GAO·February 11, 2015

    Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GDW·February 11, 2015

    Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GEI·February 11, 2015

    Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code GDW·February 11, 2015