Reported Nov 6, 2019 · Terminated
Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO -…
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?
- Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651
- STERILEEO -
- Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
- Lot codes and dates
25 of 25 products · 25 lot codes
Recalled lot codes, grouped by product number Lot Numbers UDI 0000000985(01)04546540688781(17)201031(10)0000000985
0000001020(01)04546540688781(17)201031(10)0000001020
0000001499(01)04546540688781(17)201031(10)0000001499
0000001916(01)04546540688781(17)201130(10)0000001916
0000001645(01)04546540688781(17)201130(10)0000001645
0000002060(01)04546540688781(17)201130(10)0000002060
0000002061(01)04546540688781(17)201130(10)0000002061
0000002979(01)04546540688781(17)201231(10)0000002979
0000003123(01)04546540688781(17)201231(10)0000003123
0000003771(01)04546540688781(17)210131(10)0000003771
- Amount recalled
- 2421
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 product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
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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