Reported Nov 6, 2019 · Terminated
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, 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 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641
- STERILEEO -
- Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
- Lot codes and dates
116 of 116 products · 116 lot codes
Recalled lot codes, grouped by product number Lot Numbers UDI 0000000564(01)04546540688767(17)201031(10) 0000000564
0000000565(01)04546540688767(17)201031(10)0000000565
0000000566(01)04546540688767(17)201031(10)0000000566
0000000673(01)04546540688767(17)201031(10)0000000673
0000000674(01)04546540688767(17)201031(10)0000000674
0000000675(01)04546540688767(17)201031(10)0000000675
0000000983(01)04546540688767(17)201031(10)0000000983
0000000982(01)04546540688767(17)201031(10)0000000982
0000001016(01)04546540688767(17)201031(10)0000001016
0000001017(01)04546540688767(17)201031(10)0000001017
- Amount recalled
- 21971
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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