Reported Dec 17, 2014 · Terminated
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the…
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 endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.
- Lot codes and dates
36 of 36 products
Products covered by this recall Model / number Product as published — Novak Biopsy Suct Curette, x-del, 2 mm, 9" 320-05942Instrumed — Trade Name: Medline Industries — Medline Industries Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9" MDG2480081Medline Industries — Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9" 320-05942Instrumed — Trade Name: Medline Industries — Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9", 23 CM MDG2480091Medline Industries — Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9" 320-05942Instrumed — Trade Name: Boss Instruments — Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9" 46-2974Boss Instruments — Lot Number: 070512. 4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9" 320-05942Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9" 52-7050Symmetry Surgical - Amount recalled
- 26 endometrial suction curettes
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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