BEUDAMED
    284 results · 49ms · 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 ×

    HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code LJS·March 3, 2023

    HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code FOZ·December 22, 2022

    HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code FOZ·December 16, 2022

    HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code LJS·August 31, 2023

    HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code LJS·August 31, 2023

    HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code FOZ·December 16, 2022

    HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code FOZ·December 22, 2022

    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

    FDA Recall
    Terminated ·Access Vascular, Inc.·Product code LJS·February 24, 2021

    HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

    FDA Recall
    Open, Classified ·Access Vascular, Inc·Product code FOZ·December 16, 2022

    PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device. Model 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access Device Model 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access Devices

    FDA Recall
    Terminated ·Escalon Medical Corp·Product code DPW·May 5, 2010

    DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code NAC·May 18, 2026

    BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally implantable vascular access device designed to provide long term repeated access to the vascular system

    FDA Recall
    Terminated ·Bard Access Systems·August 30, 2011

    Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code DQY·July 2, 2009

    Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE. Product Number: MPCN1802. 510k K974745. Qty Dist. - 425. B) "Seldinger" Needle. STERILE. Product Number: SN1802, SN1902. 510k K974745. Qty Dist. - 5,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Vascular Access Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code DRC·September 1, 2009

    Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgically implanted vascular ports.

    FDA Recall
    Terminated ·Bard Access Systems·Product code FPA·January 14, 2010

    Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgically implanted vascular ports.

    FDA Recall
    Terminated ·Bard Access Systems·Product code FPA·January 14, 2010

    DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit - 32cm 62153228 Duraspan Kit - 36cm 62153620 Duraspan Exchange Kit - 36cm 62153628 Duraspan Kit - 40cm 62154020 Duraspan Exchange Kit - 40cm 62154028 Duraspan Kit - 55cm 62155520 Duraspan Ultra Kit - 24cm 621524E0 Duraspan Ultra Kit - 28cm 621528E0 Duraspan Ultra Kit - 36cm 621536E0 Duraspan Ultra Kit - 40cm 621540E0 Duraspan Ultra Kit - 55cm 621555E0 The r4 DuraspanTM and the DuraspanTM Ultra long-term dialysis catheter are indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.

    FDA Recall
    Terminated ·R4 Vascular Inc·Product code MSD·May 3, 2011

    Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.

    FDA Recall
    Terminated ·Arrow International Inc·Product code MSD·June 10, 2008

    Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.

    FDA Recall
    Terminated ·Arrow International Inc·Product code MSD·June 10, 2008

    ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CSD-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.

    FDA Recall
    Terminated ·Arrow International Inc·Product code MSD·June 10, 2008