BEUDAMED
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    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.

    FDA Enforcement
    Class II ·Terminated·Richard Wolf Medical Instruments Corp.·October 15, 2014

    ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing.

    FDA Enforcement
    Class II ·Terminated·Assuramed·September 25, 2013

    Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·June 25, 2014

    Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.

    FDA Enforcement
    Class II ·Terminated·Richard Wolf Medical Instruments Corp.·November 13, 2013

    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.

    FDA Enforcement
    Class II ·Terminated·Maytex Corp·June 12, 2013

    Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Ltd., Singapore. The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

    FDA Recall
    Terminated ·Progressive Medical Inc·Product code MEB·July 28, 2011

    McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2' wide; 16-1033-3-STR, 3' wide; 16-1033-4-STR, 4' wide; and 16-1033-6-STR, 6' wide

    FDA Recall
    Terminated ·Cypress Medical Products, Ltd.·Product code FQM·December 2, 2004

    Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·October 2, 2013

    Case Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-103 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free Contents: 1 - Graduated Tray, 1200 cc 1 - Green Bulb Syringe (Catheter Tip), 60 cc 1 - Graduated Solution Container, 500 cc 1- Underpad, 1 - Sterile Alcohol Prep Pad Reorder No. 37-103 Contents STERILE in unopened, undamaged package. Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Usage: The trays are irrigation trays for catheters

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: McKESSON Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON LATEX FREE Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-14 FR Plastic Catheter Reorder No. 37-231 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Case Label: McKesson Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-104 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc 1 - Thumb Control Ring Piston Syringe (Catheter Tip), 60 cc 1- Graduated Solution Container, 500 cc, 1 - Underpad, 1-Sterile Alcohol Prep Pad Reorder No. 37-104 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Intended use: The trays are irrigation trays for catheters

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code FCM·January 20, 2011

    Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-232 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Urethral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable Contents: 1-14 FR Red Rubber Catheter, 1-Pair of Vinyl Gloves, 1-Specimen Container with Lid and Label, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Pack of Lubricating Jelly, 1- Polylined Drape, 1-Graduated Tray, 1200 cc Reorder No. 37-232 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9" x 9" towelette, pre-moistened with 0.525% - 0.656% sodium hypochlorite, packaged in a flexible poly foil pouch, 50 wipes per dispenser box, 8 boxes per case; Manufactured for Metrex Research Corporation, 28210 Wick Road, Romulus, MI 48174. General purpose disinfectant wipe for hard, non-porous surfaces, patient care equipment and point of care equipment.

    FDA Recall
    Terminated ·Medtrol, Inc.·Product code LRJ·December 2, 2009

    Case Label: McKESSON Medi-Pak Uretheral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-202 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray label: McKesson Medi-Pak Urethral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable Contents: 1-14FR Red Rubber Catheter, 1-Pair of Vinyl Gloves, 1-Specimen Container with Lid and Label, 1-Fenestrated Drape, 1-Pack of PVP Solution, 1-Pack of Lubricating Jelly, 1-Pair of Forceps, 5-Rayon Balls in One Prep Cup, 1-Polylined Drape, 1-CSR Wrap, 1 Graduated Tray, 1200 cc Reorder No. 37-202 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

    HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

    HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

    HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614SPL Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

    Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.

    FDA Recall
    Terminated ·Celsion Corporation·Product code MEQ·May 4, 2006

    Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-30 cc Syringe, Pre-Filled with Sterile Water Reorder No. 37-234 Contents STERILE In unopened, undamaged package. Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011