Class 2 Device Recall CooperSurgical

• Date Initiated by Firm: March 09, 2015
• Date Posted: April 16, 2015
• Recall Status: Terminated on February 01, 2016
• Recall Number: Z-1450-2015
• Recall Event ID: 70829
• 510(K)Number: K803311
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 75 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: 203-601-9818
• Manufacturer Reason for Recall: Internal gas line may malfunction causing the line to burst under pressure.
• FDA Determined Cause: Under Investigation by firm
• 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.
• Quantity in Commerce: 255 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEH