LAP CHOLE PACK. Medical convenience kit.
- Company
- Avid Medical, Inc.
- Recall Initiated
- June 11, 2025
- Posted
- August 4, 2025
- Recall Number
- Z-2253-2025
- Quantity
- 85 units
- Firm Location
- Toano, VA
Reason for Recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Distribution
Domestic: CA, IL, MD, OH, PA, TX, WA.
Lot / Code Info
Model No. VCIH007-06; UDI: 10809160379479, 10809160450758; Kit Lot No. 1569227, 1569228, 1569229, 1589126, 1608615, 1623944, 1643426.
Root Cause
Under Investigation by firm
Action Taken
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