Home / Recalls / Intuitive Surgical, Inc. / Z-0106-2022

Z-0106-2022 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
October 20, 2021
Initiation Date
August 6, 2021
Termination Date
May 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1625 units

Product Description

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

Reason for Recall

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

Distribution Pattern

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

Code Information

Affected Lot Number(s): S90200303, S90200622, S90200727, S90200811, S90200820, S90200831 ,S90200909, S90201008, S90201015 ,S90201103, S90201107, S90201125 ,S90201202, S90201204, S90210114 ,S90210211, S90210225, S90210310 ,S90210318, S90210408, S90210414

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