Reported Nov 6, 2019 · Terminated
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, 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?
Synchro20.014 in x 200cmSOFT Guidewire with Hydrophilic CoatingUPN Product No. M00326010 REF 2601
- STERILEEO -
- Product Usageproduct is intended for general intravascular use, including neurovascular and peripheral vasculatures
- Lot codes and dates
70 of 70 products · 70 lot codes
Recalled lot codes, grouped by product number Lot Numbers UDI 0000000558(01)04546540688729(17)201031(10)0000000558
0000000560(01)04546540688729(17)201031(10)0000000560
0000000671(01)04546540688729(17)201031(10)0000000671
0000000672(01)04546540688729(17)201031(10)0000000672
0000000980(01)04546540688729(17)201031(10)0000000980
0000000987(01)04546540688729(17)201031(10)0000000987
0000001013(01)04546540688729(17)201031(10)0000001013
0000001014(01)04546540688729(17)201031(10)0000001014
0000001275(01)04546540688729(17)201031(10)0000001275
0000001274(01)04546540688729(17)201031(10)0000001274
- Amount recalled
- 13503
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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