Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This 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.
FDA Recall Z-2148-2019 · Posted None
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Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeEOQ
Date Initiated2019-04-01
Date Terminated2020-06-09
Product Quantity310000
Reason for Recall
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Firm Action
Urgent Medical Device Correction letters dated 4/1/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions call 484-896-5688.
Root Cause
Process control
Distribution Pattern
The products were distributed US Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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