Reported Nov 6, 2019 · Terminated
Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, 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 SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631
- STERILEEO -
- Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
- Lot codes and dates
11 of 11 products · 11 lot codes
Recalled lot codes, grouped by product number Lot Numbers UDI 0000000563(01)04546540688743(17)201031(10)0000000563
0000000986(01)04546540688743(17)201031(10)0000000986
0000001646(01)04546540688743(17)201130(10)0000001646
0000002238(01)04546540688743(17)201130(10)0000002238
0000002426(01)04546540688743(17)201231(10)0000002426
0000002640(01)04546540688743(17)201231(10)0000002640
0000003465(01)04546540688743(17)210131(10)0000003465
0000004906(01)04546540688743(17)210228(10)0000004906
0000005147(01)04546540688743(17)210228(10)0000005147
0000005343(01)04546540688743(17)210228(10)0000005343
- Amount recalled
- 831
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 notice does not describe the hazard.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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