Class 2 Device Recall CT DAVINCI

• Date Initiated by Firm: June 11, 2025
• Date Posted: August 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2242-2025
• Recall Event ID: 97149
• Product Classification: Obstetrical kit - Product Code OKV
• Product: CT DAVINCI. Medical convenience kit.
• Code Information: Model No. WRNM089; UDI: 10809160432525; Kit Lot No. 1627141.
• FEI Number: 1047429
• Recalling Firm/ Manufacturer: AVID Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Marlene Jones; 757-566-3510
• Manufacturer Reason for Recall: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
• FDA Determined Cause: Under Investigation by firm
• Action: Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to complaints@owens-minor.com
• Quantity in Commerce: 12 units
• Distribution: Domestic: CA, IL, MD, OH, PA, TX, WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.