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Soma Access Systems LLC recalls AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for E
Recalled November 26, 2014 · FDA recall Z-0215-2015 · Soma Access Systems
Hazard
There is a possibility the sterile packaging may fail before the expiration date specified on the package. · FDA Class II
Units
3530 units
Sold at
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.
Description
There is a possibility the sterile packaging may fail before the expiration date specified on the package.
Product
AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.
Manufacturer(s)
Soma Access Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →