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Intuitive Surgical, Inc. recalls Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI
Recalled October 20, 2021 · FDA recall Z-0106-2022 · Intuitive Surgical
Hazard
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. · FDA Class II
Units
1625 units
Sold at
US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China
Description
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Product
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →