Z-0488-2015 Class III Terminated
FDA device recall Z-0488-2015 was initiated by CooperSurgical, Inc. on Oct 27, 2014 and is designated Class III. Reason for recall: The product has been identified to contain an incorrect curette type. The recall status is terminated (terminated May 28, 2015). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 10, 2014
- Initiation Date
- Oct 27, 2014
- Termination Date
- May 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
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.
Distribution Pattern
US Distribution including the states of NY, MO and NV.
Code Information
Lot Code: 147234
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0488-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026