Recall Z-2148-2019 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
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.
| Date | Apr 1, 2019 |
| Status | Terminated |
| Reason | There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope. |
| Root cause | Process control |
| 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. |
| Quantity | 310000 |
| Distribution | The products were distributed US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920025 | OLYMPUS DISPOSABLE SUCTION VALVE Olympus Corp., Mar 24, 1992 |