Expanded list of Urology and OR room specific kits and trays. Potential lack of sterility assurance which could result in non-sterile product.
Compare the exact product and every lot, model, serial range or date listed in the official notice. A similar name alone does not establish that your product is included.
This imported record does not provide a separate identifier list. Read the complete official notice for the affected products and restrictions.
Manufacturer & model: Device name, model or catalog number from its label or packaging. Serial, lot or UDI: The identifiers specified in the notice; retain packaging where possible. Version & care records: Software version when relevant, or an implant card and clinician’s records.
Read the medical devices identification guideWhy this notice was issued
Potential lack of sterility assurance which could result in non-sterile product
Official action
Open the official FDA notice to confirm whether your product is included and read the current instructions from the agency and manufacturer.
Follow the specific instructions and use the contact details in the announcement if you need help confirming a match or arranging the remedy.
Read the full official instructionsProduct & source details
- Product
- Expanded list of Urology and OR room specific kits and trays
- Brand or manufacturer
- Covidien and Cardinal Health
- Source
- FDA
- Notice type
- Recall
- Category
- Medical devices