BEUDAMED
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    ANGIOVAC

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC.·Product code DWF·October 16, 2014

    Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.

    FDA Recall
    Terminated ·Inrad, Inc·Product code GAA·December 20, 2010

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Blue Belt Technologies MN·August 28, 2013

    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.

    FDA Enforcement
    Class II ·Terminated·Nanosphere, Inc.·October 1, 2014

    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

    FDA Enforcement
    Class II ·Terminated·Owens & Minor Distribution, Inc.·May 8, 2013

    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 4, 2012

    Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.

    FDA Recall
    Terminated ·Porex Surgical, Inc.·Product code HQN·March 28, 2008

    NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration

    FDA Recall
    Terminated ·Collagen Matrix Inc·Product code NPM·May 13, 2013

    EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code CGA·September 18, 2019

    Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007023, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 006035, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" , REF 003028, 28F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., FASTRAC* Guidewire Gastric Access Port Safety System, REF 006034, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 006036, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003025, 16F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, 16F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003027, 28F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008