Reported Dec 17, 2014 · Terminated
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry…
Instrumed International, Inc.
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: Instrumed International, Inc. · 626 Cooper Ct · Schaumburg, IL · 60173-4537
Is this the product you have?
- An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.
- Lot codes and dates
186 of 186 products
Products covered by this recall Model / number Product as published — Valvulotome 6 1/4" Retrograde 500-05626Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Valvulotome 6 1/4" Retrograde 55-8685Symmetry Surgical — Lot Numbers: 030412, 060413, 070513. 2) Instrumed Product Name: Valvulotome 6 1/4" Retrograde 500-05626Instrumed — Trade Name: CareFusion — CareFusion Product Name: Valvulotome 6 1/4" Retrograde 55-8685CareFusion — Lot Number: 070513. 3) Instrumed Product Name: Valvulotome 6 1/4" Retrograde 500-05626Instrumed — Trade Name: Boss Instruments — Boss Instruments Product Name: Valvulotome, retro, 6 1/4" 65-7048Boss Instruments — Lot Numbers: 030412, 060413, 070513, 110411. 4) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle 500-05631Instrumed — Trade Name: Phoenix Instruments — Phoenix Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle 155-8680Phoenix Instruments - Amount recalled
- 479 valvulotomes
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
Why it was recalled
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
This product could cause temporary or reversible health problems — stop using it.
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