BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY 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 FMH·May 20, 2014

    Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.

    FDA Recall
    Terminated ·Thermo Fisher Scientific (Monterrey) Blvd Apodaca 500 Apodaca Technology Park Apodaca Nuevo Leon 66600 Mexico·Product code FMH·April 29, 2020

    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.

    FDA Recall
    Terminated ·Bard Medical Division·Product code FMH·March 21, 2018

    Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code FMH·December 11, 2019

    , Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FMH·October 8, 2014

    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099

    FDA Recall
    Terminated ·Covidien LLC·Product code FMH·October 14, 2016

    Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905

    FDA Recall
    Terminated ·Thermo Fisher Scientific (Monterrey) Blvd Apodaca 500 Apodaca Technology Park Apodaca Nuevo Leon 66600 Mexico·Product code FMH·July 18, 2019

    Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904

    FDA Recall
    Terminated ·Thermo Fisher Scientific (Monterrey) Blvd Apodaca 500 Apodaca Technology Park Apodaca Nuevo Leon 66600 Mexico·Product code FMH·July 18, 2019

    BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMH·February 14, 2013

    CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FMH·July 10, 2015

    Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·March 29, 2010

    BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·November 13, 2006

    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

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Enforcement
    Class II ·Terminated·FMS, Finapres Medical Systems BV·August 15, 2012

    BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 23, 2006

    Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560) Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The equipment is intended for transferring lifts from one system track to another.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·August 1, 2008

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Recall
    Terminated ·FMS, Finapres Medical Systems BV Paasheuvelweg 34A 1105 BJ Amsterdam Netherlands·Product code DXN·July 6, 2012

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.

    FDA Recall
    Terminated ·Mesa Laboratories, Inc.·Product code FKH·May 12, 2017