Device 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.
Z-0488-2015
Product summary
- Event
- Event 69642
- Status
- Terminated
- Classification
- Class III
- Quantity
- 30
- Official record key
device-enforcement:Z-0488-2015
Official wording
Reason: The product has been identified to contain an incorrect curette type.
Code information: Lot Code: 147234
Distribution pattern: US Distribution including the states of NY, MO and NV.
Derived failure modes
-
Unknown
The product has been identified to contain an incorrect curette type.