FDA Recall Terminated

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.

Recall: Z-0533-2015 · Initiated September 8, 2014

Recall

Recall Number: Z-0533-2015
Event Number: 69471
Firm: Instrumed International, Inc.
FEI Number: 1421101
Product Code: HHK
Status: Terminated
Root Cause: No Marketing Application
Initiated: September 8, 2014
Posted: December 16, 2014
Terminated: November 29, 2017
Address: 626 Cooper Ct, Schaumburg, IL, 60173-4537

Description

Reason

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

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.

Distribution

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Quantity

26 endometrial suction curettes