CooperSurgical, Inc.: 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

Recalling firm

CooperSurgical, Inc.

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

Status

Terminated

Initiated

2015-03-09

Posted

2015-04-16

Terminated

2016-02-01

Reason

Internal gas line may malfunction causing the line to burst under pressure.

Root 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

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.

Lot, serial or model codes

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

510(k) numbers

["K803311"]

PMA numbers

not on file

Product code

GEH

Firm FEI

1216677

Firm city

Trumbull

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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