Devices

Device Recall Centurion

  • Modèle / numéro de série
    0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers 4128353, 3046276, 3024261 were utilized in the following Centurion convenience kits: Kit Code/Description: CVI3210/UNIVERSAL CENTRAL LINE INSERTION, Lot Numbers: 2013082850, 2013092650; Kit Code/Description: CVI3240/PORT ACCESS KIT, Lot Number: 2013111180;  Kit Code/Description: CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers: 2013081350,2013082950, 2013091250;  Kit Code/Description: CVI3525/UNIVERSAL BUNDLE PACK, Lot Number: 2013052880; Kit Code/Description: CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers: 2013092450, 2013081950; Kit Code/Description: DT10560/INFUSION PORT ACCESS KIT, Lot Number: 2013061780;  Kit Code/Description: DT10620/FISTULA KIT, Lot Number: 2013082150; Kit Code/Description: DT11270/VAD KIT, Lot Number: 2013051380;  Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980; Kit Code/Description: DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers: 2013052880,  2013111180;  Kit Code/Description: DT12955/UNIVERSAL PROCEDURE PACK, Lot Number: 2013091750;  Kit Code/Description: DT13610/PICC INSERTION KIT, Lot Numbers: 2013061780, 2013062480; Kit Code/Description: DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number: 2013052080;  Kit Code/Description: DT14645/PORT ACCESS TRAY, Lot Number: 2013120280;  Kit Code/Description: DT14680/CAP CHANGING KIT, Lot Numbers: 2013061080, 2013061780; Kit Code/Description: DT14835/CAP CHANGE KIT, Lot Number: 2013111180; Kit Code/Description: DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number: 2013102880; Kit Code/Description: DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers: 2013050680, 2013040180, 2013061080;  Kit Code/Description: DT15220/STERILE CAP CHANGE, Lot Numbers: 2013052880, 2013061080; Kit Code/Description: DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880,2013061780, 2013072980, 2013111180;  Kit Code/Description: DT17300/NEONATAL CAP CHANGE KIT, Lot Numbers: 2013052880, 2013111880; Kit Code/Description: DT17410/ON/OFF KIT & DRESSING CHANGE TRAY, Lot Numbers: 2013050680, 2013061780; Kit Code/Description: DT17880C/DRIVELINE MGMT SYST - PROTOCOL 2, Lot Number: 2013040180;  Kit Code/Description: ECVC150/MULTI-LUMEN CVC KIT W/ELS VANTEX CATHETE, Lot Number: 2013091950;  Kit Code/Description: ECVC355/ CHARLES COLE CVC INSERTION BUNDLE, Lot Numbers: 2013082050, 2013091950; Kit Code/Description: ECVC510/CENTRAL LINE INSERTION TRAY, Lot Number: 2013081550; Kit Code/Description: ECVC585/CENTRAL LINE INSERTION TRAY BUNDLE, Lot Number: 2013082950; Kit Code/Description: ECVC705/7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Lot Number: 2013091750;  Kit Code/Description: ECVC740/MULTI-LUMEN CVC BUNDLE, Lot Number: 2013092650; Kit Code/Description: HT5525/V.A.D.KIT, Lot Number: 2013062480; Kit Code/Description: HT5545/SUB-PORT ACCESS TRAY: Lot Number: 2013052880; & Kit Code/Description: IV7610/ARTERIAL LINE INSERTION KIT, Lot Numbers: 2013052080.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD.
  • Description du dispositif
    0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
  • Manufacturer
    Centurion Medical Products Corporation
  • 1 Event

Fabricant

Centurion Medical Products Corporation
  • Adresse du fabricant
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA

106 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall Centurion Convenience Kits
  • Modèle / numéro de série
    ECVC1010  CVC INSERTION BUNDLE - 3L, 16CM Batch Exp. 2015042150 12/2016 2015061050 01/2017 2015062650 02/2017 2015071050 03/2017 2015081150 03/2017  ECVC1025  16CM CENTRAL LINE BUNDLE  Batch Exp. 2015052750 12/2016 2015062250 01/2017 2015070150 02/2017 2015070950 03/2017 2015080650 03/2017  ECVC1425  20CM CENTRAL LINE BUNDLE  Batch Exp. 2015041450 12/2016 2015052250 12/2016 2015062250 01/2017 2015070150 02/2017  ECVC1780  TRIPLE LUMEN BUNDLE Batch Exp. 2015041450 01/2017 2015081350 05/2017  ECVC1785  QUAD LUMEN BUNDLE Batch Exp. 2015052150 01/2017 2015061850 03/2017  ECVC3015  CVC TRIPLE LUMEN BUNDLE Batch Exp. 2015061050 01/2017 2015061850 01/2017  ECVC3260  CVC INSERT BUNDLE 16CM  Batch Exp. 2015061150 09/2016 2015061550 09/2016  ECVC3540  TRIPLE LUMEN PI CVC BUNDLE  Batch Exp. 2015041350 12/2016  ECVC3575  CVC TRIPLE LUMEN BUNDLE - 20CM  Batch Exp. 2015041550 10/2016 2015061050 01/2017  ECVC3915  VANTEX TLC KIT: CURVED SUTURE NEEDLE  Batch Exp. 2015040850 02/2017 2015042750 02/2017 2015070250 03/2017 2015081150 05/2017  ECVC3925  9F INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015071750 01/2017  ECVC405  CVC MULTI-LUMEN INSERTION BUNDLE  Batch Exp. 2015041750 12/2016 2015061050 01/2017  ECVC4095  AVA HIGH FLOW BUNDLE Batch Exp. 2015060450 08/2016  ECVC4110  MULTI-MED TLC KIT: CURVED SUTURE NDL  Batch Exp. 2015060150 03/2017 2015061550 03/2017 2015080750 04/2017  ECVC4115  6FR INTRODUCER: CURVED SUTURE NEEDLE  Batch Exp. 2015080550 01/2017  ECVC4170  AVA 3xi CVC BUNDLE  Batch Exp. 2015070250 06/2016
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
  • Description du dispositif
    Convenience Kits from Centurion that contain an In-Vision- || Plus Needleless IV Connector, Model: code RYM5001 || InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
  • Manufacturer
    Centurion Medical Products Corporation
Device Recall Centurion Medical Products
  • Modèle / numéro de série
    2009100550
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Centurion Medical Products Port access tray with sorbaview 2000 and chloraprep DT9155, Sterile
  • Manufacturer
    Centurion Medical Products
Device Recall Centurion Medical Products
  • Modèle / numéro de série
    2009092450
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Centurion Medical Products Port access tray DT9195, Sterile.
  • Manufacturer
    Centurion Medical Products
Device Recall Centurion Medical Products
  • Modèle / numéro de série
    2009102250 and 2009100950
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Centurion Medical Products VAD access tray HT2440A, Sterile
  • Manufacturer
    Centurion Medical Products
Device Recall Centurion Port Access Dressing Change Tray
  • Modèle / numéro de série
    905058, 902188, 902118, 2008101390, 2008110390, 2008120190, 2009011990, 2009012690, 2009021690, 2009040690, 2009051190, 2009060190, 2009062990, 2009072790, 2009101290, 2009110290 and 2010011890.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- AR and OH.
  • Description du dispositif
    Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
  • Manufacturer
    Centurion Medical Products
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