Recall Z-0488-2015— CooperSurgical, Inc.
Class III · Terminated
Class III FDA medical device recall by CooperSurgical, Inc., initiated 2014-10-27, terminated 2015-05-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The product has been identified to contain an incorrect curette type..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-10-27
- Terminated
- 2015-05-28
- Firm location
- Trumbull, CT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.