Reported Aug 8, 2018 · Terminated
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Galt Medical Corporation
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: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
Centeze Centesis CatheterCatalog #: a) DRC-006-05b) DRC-006-15
- Lot codes and dates
Lot #: a) 18043101b) 1812442618120765
- Amount recalled
- 300
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
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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