Non-sterile procedural trays labeled as THEDA CLARK recall: Sterility Concern
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Why was Non-sterile procedural trays labeled as THEDA CLARK recalled?
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
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?
Item Number: CDSOPP508AG, UDI/GTIN Case: 40195327145140, UDI/GTIN Each: 10195327145149, Lot Number: 22HBO323
- Product
- Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 45 units
- Distribution
- US Nationwide distribution in the states of AR, MD, WA, WI.
- Recall date
- February 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)