device · product 1 of 1
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
- Recall number
- Z-1450-2015
- Initiated
- March 09, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 255 units
App-derived interpretation
Internal gas line may malfunction causing the line to burst under pressure.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
Internal gas line may malfunction causing the line to burst under pressure.
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
Distribution pattern
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.