Z-2148-2019 Class II Terminated
FDA device recall Z-2148-2019 was initiated by Olympus Corporation of the Americas on April 1, 2019 and is designated Class II. Reason for recall: There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope. The recall status is terminated (terminated June 9, 2020). Affected quantity: 310000.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- April 1, 2019
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 310000
Product Description
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 Pattern
The products were distributed US Nationwide.
Code Information
Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H