Reported Feb 8, 2023 · Ongoing
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
- Lot codes and dates
- Item NumberCDSOPP508AG
- UDI/GTIN Case40195327145140
- UDI/GTIN Each10195327145149
- Lot Number22HBO323
- Amount recalled
- 45 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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