Reported Oct 20, 2021 · Terminated
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only,…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Ion Flexison Biopsy Needle, 19G
- Extension Range0-3 cm
- Ref490104-09 and 49004-10, 5-pack, Sterile EO, Rx only
- UDI00886874115978
- Lot codes and dates
- Affected Lot Number(s)
S90200303S90200622S90200727S90200811S90200820S90200831S90200909S90201008S90201015S90201103S90201107S90201125S90201202S90201204S90210114S90210211S90210225S90210310S90210318S90210408S90210414
- Affected Lot Number(s)
- Amount recalled
- 1625 units
Where it was sold
Why it was recalled
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
This product could cause temporary or reversible health problems — stop using it.
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