HRIS Storage & Sterilization Case and Tray recall
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Why was HRIS Storage & Sterilization Case and Tray recalled?
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Part 6210-9-900, UDI-DI: 07613327217902, Lot#: All lots back to 2006.
- Product
- HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 630 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.
- Recall date
- June 26, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)