Recall Z-1450-2015 ยท GEH Unit, Cryosurgical, Accessories
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
| Date | Apr 16, 2015 (initiated Mar 9, 2015) |
| Status | Terminated |
| 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K803311 | LL100 CRYOSURGICAL SYSTEM Wallach Surgical Devices, Inc., Feb 4, 1981 |