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:00886874115978
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Read the official notice →- Date
- 2021-10-20
- Country
- United States
- Brand
- Intuitive Surgical
- 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
- Classification
- Class II
- Units
- US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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