| Class 2 Device Recall Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, Adler Instrument Company | |
Date Initiated by Firm | September 08, 2014 |
Date Posted | December 16, 2014 |
Recall Status1 |
Terminated 3 on November 29, 2017 |
Recall Number | Z-0533-2015 |
Recall Event ID |
69471 |
Product Classification |
Curette, suction, endometrial (and accessories) - Product Code HHK
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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 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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Instrumed International, Inc. 626 Cooper Ct Schaumburg IL 60173-4537
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For Additional Information Contact | Ms. Jennifer S. Staunton 847-908-6119 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | No Marketing Application |
Action | Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119. |
Quantity in Commerce | 26 endometrial suction curettes |
Distribution | Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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