Reported Nov 6, 2019 · Terminated
Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611,…
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, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611
- STERILEEO -
- Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
- Lot codes and dates
27 of 27 products · 27 lot codes
Recalled lot codes, grouped by product number Lot Numbers UDI 0000000562(01)04546540688736(17)201031(10)0000000562
0000001015(01)04546540688736(17)201031(10)0000001015
0000001277(01)04546540688736(17)201031(10)0000001277
0000001288(01)04546540688736(17)201031(10)0000001288
0000001494(01)04546540688736(17)201031(10)0000001494
0000000981(01)04546540688736(17)201031(10)0000000981
0000002055(01)04546540688736(17)201130(10)0000002055
0000002239(01)04546540688736(17)201130(10)0000002239
0000002973(01)04546540688736(17)201231(10)0000002973
0000003130(01)04546540688736(17)201231(10)0000003130
- Amount recalled
- 3720
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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