BEUDAMED
    159 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer Lock SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide.

    FDA Recall
    Terminated ·Cook Inc.·Product code DYB·May 28, 2015

    Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and Luer Activated Y-Injection Sites. (Approx. 10 Drop/ML). An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang Pressure Activated Manifold Valve. (Approx. 10 Drops/ML); with Two Y-Injection Sites and Rotating Luer Lock (Approx. 10 Drop/ML); with Positive Pressure Pump with 4-Way "Hi-Flo" Stopcock and 4 Pre-Pierced "Y" Injection Sites (approx. 10 Drop/mL). An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM)Injection Sites and Rotating Male Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc; with 2""Hi-Flo" Stopcocks, Twin Y Injection Sites and Detachable 8" Extension with Retractable Luer-Lock; with Two SmartSite(TM) Y-injection Sites. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrogenic fluid pathway; solution set: 74'', 60 drops/mL, with injection site and male Luer Lock adapter, manifold extension set: 29'', 4 mL Vol, male luer adapter, and minivolume extension set: 7'', 0.4 mL Vol with retractable T-connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·December 15, 2005

    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.

    FDA Recall
    Terminated ·Repro-Med Systems, Inc.·Product code FRN·March 10, 2016

    Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 1C8533 Intended use: for the administration of sterile I.V. fluids to the patient

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·December 6, 2011

    Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 3-Way Stopcock Manifold, Extension Set, 44" (112 cm), Vol. 6.6 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 1C8369. Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·December 6, 2011

    Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock,, Extension Set, 61" (155 cm), Vol. 8.5 mL, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 1C8371 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·December 6, 2011

    Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box Label ***smith&nephew***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: smith&nephew Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** -------------------- Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: ***smith&Nephew***#59403125***REMOVE***US Patent no. 5336207***CE***. Formulation F-57 S&N Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. Formulation F-57 S&N Product Code 59403125 REMOVE CE Adhesive Remover. Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. .

    FDA Recall
    Terminated ·Smith & Nephew Inc.·Product code KOX·April 4, 2011

    Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock, Extension Set, 39" (99 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, Extension Set, 8" (20 cm), Vol. 1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 3C0142 Intended use: for the administration of sterile I.V. fluids to the patient

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·December 6, 2011

    Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Extension Set, Vol. 5.6 mL, Length 39" (99 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2C6951 Intended use: for the administration of sterile I.V. fluids to the patient

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·December 6, 2011

    Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, Length 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2C6931 Intended use: for the administration of sterile I.V. fluids to the patient

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·December 6, 2011

    Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.25 GLOBAL; g) Product Code FT12250, 2.50 GLOBAL; h) Product Code FT12275, 2.75 GLOBAL; i) Product Code FT12300, 3.00 GLOBAL

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DXC·December 6, 2023

    Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) KCFW-9.0-35-38.5-RB-RTPS-100; 8) KCFW-10.0-35-RB-RTPS-100; 9) KCFW-9.0-38-55-RB-RAABE; 10) KCFW-9.0-38-70-RB-RAABE; 11) KCFW-9.0-38-80-RB; 12) KCFW-10.0-38-30-RB; 13) KCFW-10.0-38-40-RB; 14) KCFW-10.0-38-80-RB; 15) KCFW-10.0-38-RB; 16) KCFW-12.0-38-40-RB; 17) KCFW-12.0-38-80-RB; Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DYB·November 26, 2025

    All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris Burette Set, Cardinal Health SmartSite Infusion Set, Alaris Infusion Set, Alaris SmartSite Burette Set, Cardinal Health SmartSite Burette Set, Alaris SmartSite Administration Set, Alaris Infusion Burette Set, Alaris SmartSite Blood Set, Cardinal Health SmartSite Combination Infusion Set, Cardinal Health Blood Set, Alaris Medley/Gemini Infusion Set, Alaris Medley/Gemini Blood Set, Alaris Latex-Free Infusion Set, Alaris Light Sensitive Solution Set, Alaris Medley/Gemini Enteral Set, Imed Gemini 20 Vented/Nonvented Primary Administration Set, Imed Vented/Nonvented Gemini Prime-Saver Set, Imed Vented/Nonvented Gemini Short Set, Alaris Half Set, Cardinal Health Half Set, Alaris Latex-Free Burette Set, Alaris Opaque Set, Alaris Medley/Gemini Combination Infusion Set

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·June 18, 2007

    ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FPA·December 12, 2019

    Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLOBAL; e) Product Code 50225: 12MM, 2.25 MM GLOBAL; f) Product Code 50250: 12MM, 2.50 MM GLOBAL; g) Product Code 50275: 12MM, 2.75 MM GLOBAL; h) Product Code 50300: 12MM, 3.00 MM GLOBAL; i) Product Code 50350: 12MM, 3.50 MM GLOBAL; j) Product Code 50400: 12MM, 4.00 MM GLOBAL; k) Product Code 60100: 30MM, 1.00 MM GLOBAL; l) Product Code 60175: 30MM, 1.75 MM GLOBAL; m) Product Code 60275: 30MM, 2.75 MM GLOBAL; n) Product Code 60300: 30MM, 3.00 MM GLOBAL; o) Product Code 60350: 30MM, 3.50 MM GLOBAL; p) Product Code 50125: 12MM, 1.25 MM GLOBAL; q) Product Code 50450BIOS: 12MM, 4.50 MM GLOBAL; r) Product Code 60125BIOS: 30MM, 1.25 MM GLOBAL; s) Product Code 60150BIOS: 30MM, 1.50 MM GLOBAL; t) Product Code 60200BIOS: 30MM, 2.00 MM GLOBAL; u) Product Code 60225BIOS: 30MM, 2.25 MM GLOBAL; v) Product Code 60250BIOS: 30MM, 2.50 MM GLOBAL; w) Product Code 60400BIOS: 30MM, 4.00 MM GLOBAL; x) Product Code 60450BIOS: 30MM, 4.50 MM GLOBAL

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DXC·December 6, 2023