BEUDAMED
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    NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code LGZ·August 6, 2021

    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code JOH·August 22, 2023

    Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code JKA·September 6, 2023

    Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

    FDA Recall
    Open, Classified ·Smiths Medical Asd Inc·Product code DRS·November 10, 2023

    Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 3, 2015

    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·May 31, 2024

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·May 31, 2024

    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·June 7, 2024

    Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·June 26, 2020

    Medex LOGICAL CATH LAB KIT, List Number M20754

    FDA Recall
    Open, Classified ·Smiths Medical Asd Inc·Product code DRS·November 10, 2023

    Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

    FDA Recall
    Open, Classified ·Smiths Medical Asd Inc·Product code DRS·November 10, 2023

    Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BZA·April 5, 2023

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·May 29, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·May 29, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·May 29, 2024

    smiths medical portex, Y' PIECE 15MM, REF 100/276/000

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BYD·July 18, 2024

    medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024

    medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code DPT·September 24, 2024