Reported Jun 5, 2019 · Terminated
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425,…
Terumo Medical Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Terumo Medical Corporation · 950 Elkton Blvd · Elkton, MD · 21921-5322
Is this the product you have?
SOLOPATH Re-Collapsible Access SystemModel Numbers SR-1925SR-1935SR-2025SR-2035SR-2225SR-2235SR-2425SR-2435
- Lot codes and dates
- Lot Codes
VG26VH21VL20VL29VN29WP05VG02VG07VG13VK29VL18WA25WD02WE25WF09WK01WK09WP05XA09VG06VH27VK04XA09VH27VK07VL28WL14XA30VF31VG16VH21WE25WH23WK01VG09VG14VL14VP18WN07XA09
- Lot Codes
- Amount recalled
- 1431
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Using this product could cause serious injury, illness or death — stop using it now.
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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