STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling 1,757 stainless steel reprocessing trays (Model No. 400498-02) designed for use with 8mm endoscopes and handheld cameras during minimally invasive surgery. The recall was issued because small but detectable holes in the sterilization wrap used with these trays could compromise sterility and create a risk of infection. Certain features on the trays combined with handling and storage practices may cause these holes to develop.
The affected trays were distributed worldwide and throughout the United States. The recall covers all batch numbers of this model. The source record does not specify a remedy or recommended course of action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
Reason for recall: Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes. Distribution: Worldwide distribution - US Nationwide distribution including in the states of Arkansas, Arizona, Alabama, Alaska, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Idaho, Kentucky, Kansas, Louisiana, Missouri, Michigan, Maryland, Mississippi, Minnesota, Montana, Maine, Massachusetts, Nevada, New York, North Dakota, Nebraska, North Carolina, New Jersey, Ohio, Ok Quantity: 1757 Trays Lot/code info: Model No. 400498-02; All Batch Numbers; UDI: 00886874115848
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.