PlainRecalls
FDA Devices Low Class III Terminated

Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available

Reported: December 10, 2014 Initiated: October 27, 2014 #Z-0488-2015

Product Description

Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.

Reason for Recall

The product has been identified to contain an incorrect curette type.

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
30
Distribution
US Distribution including the states of NY, MO and NV.
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.. Recalled by CooperSurgical, Inc.. Units affected: 30.
Why was this product recalled?
The product has been identified to contain an incorrect curette type.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 10, 2014. Severity: Low. Recall number: Z-0488-2015.