FDA-Device2012-10-03Class II
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
Linvatec Corp. dba ConMed Linvatec
Hazard
ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents.
Sold states
Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.
Affected count
30064 units
Manufactured in
11311 Concept Blvd, N/A, Largo, FL, United States
Products
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2469-2012Don't want to check this manually?
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