Reported Jun 5, 2024 · Ongoing
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310…
Stryker Neurovascular
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: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
Synchro .014"guide wire35 cm tip
- Catalog
M00313010 Synchro .014 guide wire300 cm length
- CatalogM00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm
- CatalogM00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm
- CatalogM00316330
- Lot codes and dates
4 of 4 products · 9 lot codes
Recalled lot codes, grouped by product number Catalog UDI-DI Lot M0031301007613252186922123279123364123404123985124214124216
M0031331007613252186946123494
M0031631007613252187158123851
M0031633007613252187165124156
- Amount recalled
- 2859
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
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
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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