BEUDAMED
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    Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.

    FDA Recall
    Terminated ·Isopure Corp·Product code FJP·May 19, 2011

    PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

    FDA Recall
    Terminated ·Medtest Holdings, Inc.·Product code CGS·October 19, 2011

    Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·September 19, 2011

    Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.) Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2" -2 3/4"/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark. These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code EXB·July 27, 2011

    LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWS·December 19, 2011

    TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 19, 2011

    Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·January 19, 2011

    THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code MSD·May 19, 2011

    Pulstar(R) DVT PREVENTION SYSTEM, Anti-Embolism Wrap System, albahealth(R), A Subsidiary of Encompass Group, LLC. Prevention of DVT.

    FDA Recall
    Terminated ·Albahealth LLC·Product code JOW·October 12, 2011

    Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.

    FDA Recall
    Terminated ·Biomet Spine, LLC·Product code NKB·December 19, 2011

    Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.

    FDA Recall
    Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code CCK·April 19, 2011

    Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1

    FDA Recall
    Terminated ·Maquet Inc.·Product code LFQO·September 19, 2011

    Maquet Servo-i ventilator system Device Part number 64 87 800 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.

    FDA Recall
    Terminated ·Maquet Inc.·Product code CBK·September 19, 2011

    The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code LGW·December 19, 2011

    Maquet PC Board PC1772 Spare Part Device Part number 64 67 620 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.

    FDA Recall
    Terminated ·Maquet Inc.·Product code CBK·September 19, 2011

    Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code LGW·December 19, 2011

    Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.

    FDA Recall
    Terminated ·Maquet Inc.·Product code CBK·September 19, 2011

    Hamamatsu model L10951-35 Micro Focus x-ray generator. The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies.

    FDA Recall
    Terminated ·Hamamatsu Corporation·Product code RBS·July 7, 2011

    BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·January 19, 2011