Events

Recall of Device Recall CooperSurgical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CooperSurgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70829
  • Event Risk Class
    Class 2
  • Event Number
    Z-1450-2015
  • Event Initiated Date
    2015-03-09
  • Event Date Posted
    2015-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135001
  • Notes / Alerts
    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.
  • Extra notes in the data
    Unit, cryosurgical, accessories - Product Code GEH
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.
  • Manufacturer Address
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA