Reported Aug 14, 2019 · Terminated
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be…
Olympus Corporation of the Americas
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: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- Olympus MAJ-209 Single Use Suction Valves
- Model Number MAJ-209 Product UsageThis product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models
- Lot codes and dates
- Lot numbers
88H89H8XH8YH8ZH91H
- Lot numbers
- Amount recalled
- 310000
Where it was sold
- Nationwide
Why it was recalled
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
This product could cause temporary or reversible health problems — stop using it.
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