Recall Z-0288-2024
Olympus Corporation of the Americas · initiated October 2, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EVIS EXERA III Gastrointestinal Videoscope
Codes / lots: Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
Reason for recall
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
FDA-determined cause: Reprocessing Controls
Action taken
The firm distributed recall notifications via mail to consignees dated 10/02/2023. Consignees are asked to inspect inventory for affected devices, ensure that all reprocessing personnel are aware and knowledgeable of the recall notice and its contents, and acknowledge receipt of the recall notification by returning the enclosed response form via email to olympus5381@sedgwick.com or by fax at 800-913-4345. Customers with any questions about the acknowledgement form are to call 866-912-9544. Customers with any questions about the recall are to contact Cynthia Ow by phone at 647-999-3203 or by email at Cynthia.Ow@Olympus.com.
Details
- Recall number
- Z-0288-2024
- Initiated
- October 2, 2023
- Posted by FDA
- November 9, 2023
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Quantity
- 1687 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA