Reported Sep 27, 2023 · Ongoing
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
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 5 3x65
- REF0915612-06, sterile for single use, Sterile EO, Rx Only
- Lot codes and dates
- UDI04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461
- Amount recalled
- 218 units
Where it was sold
Why it was recalled
Flexible intubation endoscopes sterility assurance can not be confirmed.
This product could cause temporary or reversible health problems — stop using it.
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