FDA Recall
Terminated
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.
Recall: Z-2148-2019
·
Initiated April 1, 2019
Recall
- Recall Number
- Z-2148-2019
- Event Number
- 82519
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- EOQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 1, 2019
- Terminated
- June 9, 2020
- Address
- 3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610
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
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
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.
Distribution
The products were distributed US Nationwide.
Quantity
310000