Recall Z-0533-2015— Instrumed International, Inc.
Class II · Terminated
Class II FDA medical device recall by Instrumed International, Inc., initiated 2014-09-08, terminated 2017-11-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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..
- Recalling firm
- Instrumed International, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-08
- Terminated
- 2017-11-29
- Firm location
- Schaumburg, IL, United States
Product description
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.
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.