Events

Rappel de Device Recall CooperSurgical

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par CooperSurgical, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70829
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1450-2015
  • Date de mise en oeuvre de l'événement
    2015-03-09
  • Date de publication de l'événement
    2015-04-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135001
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Unit, cryosurgical, accessories - Product Code GEH
  • Cause
    Internal gas line may malfunction causing the line to burst under pressure.
  • Action
    CooperSurgical sent an Recall letter dated March 13, 2015, shipped via Fedex with confirmed delivery receipt. The letter identified the product the problem and the action needed to be taken by the customer. No adverse events or injuries have been reported to date in connection to this recall. As stated above, the risks associated with the use of this product involve the potential for a hose to burst while under pressure. The potential hazard associated with the failure mode is negligible; there is no foreseen adverse event due to this failure mode. The event was discovered internally during an investigation. Please complete the attached Acknowledgement and Receipt Form to make repair arrangements. If you have any further questions please feel free to contact me at 203.601.5200 Monday through Friday 8:00am to 5:00pm EST.

Device

Device Recall CooperSurgical
  • Modèle / numéro de série
    Serial Numbers: 0414003, 0414004, 0414005, 0414009, 0414010, 041404, 0514001, 0514002, 0514003, 0514003, 0514004, 0514005, 0514006, 0514007, 0514008, 0514009, 0514010, 0514011, 0514012, 0514013, 0514014, 0514015, 0514016, 0514017, 0514018, 0514019, 0514020, 0514021, 0514022, 0514023, 0514024, 0514025, 0514026, 0514027, 0514028, 0514029, 0514030, 0514031, 0514032, 0514033, 0514034, 0514035, 0514036, 0514037, 0514038, 0514040, 0514041, 0514042, 0514043, 0514044, 0514045, 0514046, 0514047, 0514048, 0514049, 0514050, 0514051, 0514052, 0514053, 0514054, 0514055, 0614001, 0614007, 0614010, 061408, 0714001, 0714002, 0714003, 0714004, 0714005, 0714006, 0714007, 0714008, 0714009, 0714010, 0714011, 0714012, 0714013, 0714014, 0714015, 0714016, 0714017, 0714018, 0714019, 0714020, 0714021, 0714022, 0714023, 0714024, 0714025, 0714026, 0714027, 0714028, 0714029, 0714030, 0714031, 0714032, 0714033, 0714034, 0714035, 0814001, 0814002, 0814003, 0814004, 0814005, 0814006, 0814007, 0814008, 0814009, 0814010, 0814011, 0814012, 0814013, 0814014, 0814015, 0814016, 0814017, 0814018, 0814019, 0814020, 0814021, 0814022, 0814023, 0814024, 0814025, 0814026, 0814027, 0814028, 0814033, 0814035, 0814036, 0814037, 0814038, 0814039, 0814040, 0814041, 0814042, 0814043, 0814044, 0814046, 0814047, 0814048, 0814049, 0814050, 0814051, 0814052, 0814053, 0814054, 0814055, 0814057, 0814058, 0814059, 0814060, 0814061, 0814063, 0814064, 0814065, 0814066, 0814067, 0814068, 0914001, 0914002, 0914003, 0914004, 0914005, 0914006, 0914007, 0914008, 0914009, 0914010, 0914011, 0914012, 0914013, 0914014, 0914015, 0914016, 0914017, 0914018, 0914019, 0914020, 0914021, 0914022, 0914023, 0914024, 0914025, 1014001, 1014002, 1014003, 1014004, 1014005, 1014006, 1014007, 1014008, 1014009, 1014010, 1014011, 1014012, 1014013, 1014014, 1014015, 1014016, 1014017, 1014018, 1014019, 1014020, 1014021, 1014022, 1014023, 1014024, 1014025, 1014026, 1014027, 1014028, 1014029, 1014030, 1014031, 1014032, 1014033, 1014034, 1014035,1014037, 1014039, 1014040, 1014041, 1014042, 1014043, 1014044, 1014045, 1014046, 1014047, 1014049, 1014050, 1014051, 1014052, 1014053, 1014054, 1014055, 1014056, 1014057, 1014058, 1014059, 1014060,1014061, 1014062,1014063,1014064,1014075,1014078,1014083,1014084,1014086,1014087,1014089,1014090,1014091,1014094
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WV,. and to the countries of : CANADA, COLOMBIA, EL SALVADOR, ENGLAND, GUATEMALA, HONG KONG, INDONESIA, SINGAPORE and ZIMBABWE.
  • Description du dispositif
    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Adresse du fabricant
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Société-mère du fabricant (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA