BEUDAMED
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    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·June 11, 2014

    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    FDA Recall
    Terminated ·LAP of America Laser Applications, LLC·October 7, 2013

    BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; BHM, Magog, Canada, made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626002C-M Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626003: Combi Deluxe - Large, capacity 113-272 kg, 250-600 lbs; Part 626003M: Combi Mesh Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs. Between 2004 and 2006, the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled Medi-Man, 100% Polyester Shell, Rehabilitation Products Inc., Mississauga, Ontario, Canada L5T 1X7, made in Canada. The accessory is intended to be used with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers.

    FDA Recall
    Terminated ·B.H.M. Medical, Inc.·Product code FNG·April 7, 2009

    FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.

    FDA Enforcement
    Class I ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 18, 2012

    FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code BSZ·February 20, 2012

    Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 12, 2015

    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 10, 2008

    AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·January 27, 2011

    AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·January 27, 2011

    AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·January 27, 2011

    AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LHI·January 27, 2011

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·May 28, 2013

    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·August 31, 2016

    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·August 31, 2016

    Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following product is being recalled: "Material Number/(OUTER CARTON LABEL OF 5pk)"/"Material Number (INNER-POUCH LABEL FOR EACH SINGLE CATHETER)" / Material Description / Catalog Number. M001314001 M001314000 IMAGER II/5/ST/65/038 BX5 31-400 M001314011 M001314010 IMAGER II/5/ST/100/038 BX5 31-401 M001314021 M001314020 IMAGER II/5/ST/65/035 BX 5 31-402 M001314031 M001314030 IMAGER II/5/ST/100/035 BX 5 31-403 M001314041 M001314040 IMAGER II/5/BARNH/100/038 BX5 31-404 M001314051 M001314050 IMAGER II/5/BERN/100/038 BX5 31-405 M001314061 M001314060 IMAGER II/5/BERN/100/035 BX 5 31-406 M001314071 M001314070 IMAGER II/5/BERN/40/035 BX 5 31-407 M001314081 M001314080 IMAGER II/5/BERN/40/038 BX5 31-408 M001314091 M001314090 IMAGER II/5/BERN/65/035 BX 5 31-409 M001314101 M001314100 IMAGER II/5/BERN/65/038 BX5 31-410 M001314111 M001314110 IMAGER II/5/WEIN/100/038 BX5 31-411 M001314121 M001314120 IMAGER II/5/WEIN/100/035 BX 5 31-412 M001314131 M001314130 IMAGER II/5/H1/65/038 BX5 31-413 M001314141 M001314140 IMAGER II/5/H1/100/038 BX5 31-414 M001314151 M001314150 IMAGER II/5/H1/100/035 BX 5 31-415 M001314161 M001314160 IMAGER II/5/H3/100/038 BX5 31-416 M001314171 M001314170 IMAGER II/5/H3/100/035 BX 5 31-417 M001314181 M001314180 IMAGER II/5/H1H/100/038 BX5 31-418 M001314191 M001314190 IMAGER II/5/H1H/100/035 BX 5 31-419 M001314201 M001314200 IMAGER II/5/H3H/100/035 BX 5 31-420 M001314211 M001314210 IMAGER II/5/JB1/65/038 BX5 31-421 M001314221 M001314220 IMAGER II/5/JB1/100/038 BX5 31-422 M001314231 M001314230 IMAGER II/5/JB1/100/035 BX 5 31-423 M001314241 M001314240 IMAGER II/5/JB2/100/038 BX5 31-424 M001314251 M001314250 IMAGER II/5/JB2/100/035 BX 5 31-425 M001314261 M001314260 IMAGER II/5/JB3/100/038 BX5 31-426 M001314271 M001314270 IMAGER II/5/JB3/100/035 BX 5 31-427 M001314281 M001314280 IMAGER II/5/MAN/100/038 BX5 31-428 M001314291 M001314290 IMAGER II/5/MAN/100/035 BX 5 31-429 M001314301 M001314300 IMAGER II/5/SIM1/65/038 BX5 31-430 M001314311 M001314310 IMAGER II/5/SIM1/65/035 BX 5 31-431 M001314321 M001314320 IMAGER II/5/SIM1/100/038 BX5 31-432 M001314331 M001314330 IMAGER II/5/SIM1/100/035 BX 5 31-433 M001314341 M001314340 IMAGER II/5/SIM2/100/038 BX5 31-434 M001314351 M001314350 IMAGER II/5/SIM2/100/035 BX 5 31-435 M001314361 M001314360 IMAGER II/5/SIM3/100/038 BX5 31-436 M001314371 M001314370 IMAGER II/5/SIM3/100/035 BX 5 31-437 M001314381 M001314380 IMAGER II/5/SIM4/100/038 BX5 31-438 M001314391 M001314390 IMAGER II/5/HN1/100/038 BX5 31-439 M001314401 M001314400 IMAGER II/5/HN1/100/035 BX 5 31-440 M001314411 M001314410 IMAGER II/5/HN2/100/038 BX5 31-441 M001314421 M001314420 IMAGER II/5/HN2/100/035 BX 5 31-442 M001314431 M001314430 IMAGER II/5/HN3/100/038 BX5 31-443 M001314441 M001314440 IMAGER II/5/HN3/100/035 BX 5 31-444 M001314451 M001314450 IMAGER II/5/HN4/100/038 BX5 31-445 M001314461 M001314460 IMAGER II/5/HN4/100/035 BX 5 31-446 M001314471 M001314470 IMAGER II/5/HN5/100/038 BX5 31-447 M001314481 M001314480 IMAGER II/5/HN5/100/035 BX 5 31-448 M001314491 M001314490 IMAGER II/5/CK/100/035 BX 5 31-449 M001314501 M001314500 IMAGER II/5/GEN/100/035 BX 5 31-450 M001314511 M001314510 IMAGER II/5/GEN+2 SIDEHOLES/100/035 BX 5 31-451 M001314521 M001314520 IMAGER II/5/CHGB/65/038 BX5 31-452 M001314531 M001314530 IMAGER II/5/CHGB/65/035 BX 5 31-453 M001314541 M001314540 IMAGER II/5/CHGC/65/038 BX5 31-454 M001314551 M001314550 IMAGER II/5/CHGC/65/035 BX 5 31-455 M001314561 M001314560 IMAGER II/5/CHG2.5/65/038 BX5 31-456 M001314571 M001314570 IMAGER II/5/CHG2.5/65/035 BX 5 31-457 M001314581 M001314580 IMAGER II/5/CONTRA 2/65/038 BX5 31-458 M001314591 M001314590 IMAGER II/5/CONTRA 2/65/035 BX 5 31-459 M001314611 M001314610 IMAGER II/5/DUCK/65/035 BX 5 31-4

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQO·March 15, 2012

    ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the TissueLink BiPolar Floating Device

    FDA Recall
    Terminated ·Product code GEI·July 22, 2004

    ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device

    FDA Recall
    Terminated ·Product code GEI·July 22, 2004

    XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·November 25, 2013

    Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018

    Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·July 25, 2018