Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Reported: October 20, 2021 Initiated: August 6, 2021 #Z-0106-2022
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 1625 units
- 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
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978. Recalled by Intuitive Surgical, Inc.. Units affected: 1625 units.
Why was this product recalled? ▼
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0106-2022.
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