Stainless Steel Reprocessing Tray recall: Sterility Concern
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally…
Why was Stainless Steel Reprocessing Tray recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 400498-02; All Batch Numbers; UDI: 00886874115848
- Product
- STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 1757 Trays
- 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, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington and West Virginia. Multiple countries including Canada.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)