BEUDAMED
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    BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027 (50 count BD Test Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips), 322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health Hazard Evaluation: There is negligible medical risk to patients with diabetes using the BD blood glucose systems due to the increase of E-3 error messages.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code NBW·January 29, 2004

    Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·May 19, 2021

    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·May 8, 2013

    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures

    FDA Enforcement
    Class II ·Terminated·Opgen Inc·May 22, 2019

    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

    FDA Enforcement
    Class II ·Terminated·Richard Wolf Medical Instruments Corp.·July 17, 2019

    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code JSS·October 6, 2010

    E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·September 4, 2013

    E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code OAH·June 8, 2010

    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

    FDA Enforcement
    Class II ·Terminated·Advandx Inc·October 31, 2012

    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

    FDA Recall
    Terminated ·Advandx Inc·Product code JSS·September 14, 2012

    Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.

    FDA Recall
    Terminated ·Remel Inc·Product code JSO·April 22, 2021

    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

    FDA Recall
    Terminated ·Product code OIY·April 1, 2013

    The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose Monitor which is sold exclusively for Medtronic Mini Med. US Market BD Blood Glucose Monitoring System kit catalog Numbers: 322025 (BD Logic Blood Glucose Monitor Durable Medical Equipment consignees); 322050 (BD Latitude Diabetes Management System); 322051 (BD Logic Blood Glucose Monitor); 32205175 ( BD Logic Blood Glucose Monitor); 322200 (Paradigm Link Blood Glucose Monitor - clear); 322201 ( Paradigm Link Blood Glucose Monitor - smoke); 322202 (Paradigm Link Blood Glucose Monitor - blue); 322203 (Paradigm Link Blood Glucose Monitor - purple). Canadian market BD Blood Glucose Monitoring System kit catalog numbers: 322000 (BD Latitude Diabetes Management System); 322001 (BD Logic Blood Glucose Monitor).

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code NBW·January 29, 2004

    DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010

    AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods.

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code JSS·October 8, 2010

    DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010

    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

    FDA Recall
    Terminated ·Richard Wolf Medical Instruments Corp.·Product code HIH·May 23, 2019

    DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010

    DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010

    DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GXQ·September 29, 2010