FDA recall Z-2148-2019

Product

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.

Reason for recall

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

Distribution

The products were distributed US Nationwide.

Key facts

Status

Terminated

Initiation date

2019-04-01

Report date

2019-08-14

Termination date

2020-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2019