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
FDA Recall Z-1450-2015 · Posted 2015-04-16
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Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2015-03-09
Date Terminated2016-02-01
Product Quantity255 units
Reason for Recall
Internal gas line may malfunction causing the line to burst under pressure.
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.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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