Reported Nov 6, 2019 · Terminated
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652,…
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 PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652
- STERILEEO -
- Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
- Lot codes and dates
6 of 6 products · 6 lot codes
Recalled lot codes, grouped by product number Lot Numbers UDI 0000002431(01)04546540688798(17)201231(10)0000002431
0000002645(01)04546540688798(17)201231(10)0000002645
0000002771(01)04546540688798(17)201231(10)0000002771
0000006204(01)04546540688798(17)210331(10)0000006204
0000006875(01)04546540688798(17)210401(10)0000006875
0000007429(01)04546540688798(17)210430(10)0000007429
- Amount recalled
- 305
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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