Reported Nov 10, 2021 · Ongoing
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Karl Storz Endoscopy
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: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
- FIVE S 3.5x65, Flexible Intubation Videoscope
- REF
091361-01 (1 Unit)and 091361-06 (6 Units)
- Lot codes and dates
- All LOTs with remaining shelf life
- Amount recalled
- 532
Where it was sold
Why it was recalled
During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.
This product could cause temporary or reversible health problems — stop using it.
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