An endometrial suction curette is a device used to recall
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…
Why was An endometrial suction curette is a device used to 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Instrumed Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9"; Medline Industries Item Number: MDG2480081; Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9", 23 CM; Medline Industries Item Number: MDG2480091; Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Boss Instruments; Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9"; Boss Instruments Item Number: 46-2974; Lot Number: 070512. 4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: 52-7050; Lot Numbers: 030412, 070512, 090212, 100213, 120412. 5) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: CareFusion; CareFusion Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; CareFusion Item Number: VM57-3085; Lot Numbers: 050313, 090212, 100213. 6) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: VM57-3085; Lot Number: 050313. 7) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Adler Instrument Company; Adler Instrument Company Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Adler Instrument Company Item Number: ADG1750; Lot Number: 100213.
- Product
- 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…
- Recalling firm
- Instrumed International, Inc.
- Quantity
- 26 endometrial suction curettes
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)