Reported Nov 6, 2019 · Terminated
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642,…
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 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642
- STERILEEO -
- Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
- Lot codes and dates
37 of 37 products · 37 lot codes
Recalled lot codes, grouped by product number Lot Numbers UDI 0000000676(01)04546540688774(17)201031(10)0000000676
0000000984(01)04546540688774(17)201031(10)0000000984
0000001019(01)04546540688774(17)201031(10)0000001019
0000001281(01)04546540688774(17)201031(10)0000001281
0000001292(01)04546540688774(17)201031(10)0000001292
0000001498(01)04546540688774(17)201031(10)0000001498
0000001644(01)04546540688774(17)201130(10)0000001644
0000001915(01)04546540688774(17)201130(10)0000001915
0000002059(01)04546540688774(17)201130(10)0000002059
0000002232(01)04546540688774(17)201130(10)0000002232
- Amount recalled
- 6269
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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