Intuitive Surgical, Inc. Recall 88524
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
Intuitive Surgical, Inc. Recall 88524 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0106-2022 |
| Event ID | 88524 |
| Event 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 |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 1625 units |
| Recall Reason | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. |
| Device Classification | 20211020 |
| Device Code Info | 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 |
| Center Classification Date | 20211013 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | Intuitive Surgical, Inc. |
| Initial Notification | Letter |
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