Reported Dec 17, 2014 · Terminated
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of…
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?
- A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
- Lot codes and dates
31 of 31 products
Products covered by this recall Model / number Product as published — Nelson Patterson Trocar, lg, 12 mm 500-01938Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Nelson Patterson Trocar, lg, 12 mm 54-7004Symmetry Surgical — Lot Numbers: 050213, 100410. 2) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm 500-01938Instrumed — Trade Name: CareFusion — CareFusion Product Name: Nelson Patterson Trocar, lg, 12 mm VM72-3111CareFusion — Lot Number: 050213. 3) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm 500-01943Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm 54-7005Symmetry Surgical — Lot Number: 060312. 4) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm 500-01943Instrumed — Trade Name: Ambler Surgical — Ambler Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm 95-203Ambler Surgical - Amount recalled
- 11 trocars
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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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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