Reported Sep 18, 2024 · Ongoing
CRANIOTOMY PACK, Pack Number DYNJ46552O
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?
- CRANIOTOMY PACK, Pack Number DYNJ46552O
- Lot codes and dates
UDI/DI Case 40195327467044UDI/DI Each 10195327467043
- Lot Numbers
24ADB78823LDA93623JDB27823HDA872
- Amount recalled
- 188 units
This recall covers 106 products
The agency filed one notice per product. You are reading one of them; the other 105 are below.
93 more are in the archive.
Where it was sold
Why it was recalled
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
This product could cause temporary or reversible health problems — stop using it.
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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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