Recall Z-0488-2015 ยท HHK Curette, Suction, Endometrial (And Accessories)
CooperSurgical, Inc.
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 han
| Date | Dec 1, 2014 (initiated Oct 27, 2014) |
| Status | Terminated |
| Reason | The product has been identified to contain an incorrect curette type. |
| Root cause | Packaging process control |
| Action | CooperSurgical sent an Recall letter dated October 27, 2014, via UPS to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The subject device does not meet the required release specification as it contains an incorrect curette type. No adverse events or injuries have been reported to date in connection with the use of the CANNULA CURETTE. The event was discovered during internal investigation. Products that do not meet the above criteria are safe to use alongside the DFU guideline.The letter requests that customers return |
| Quantity | 30 |
| Distribution | US Distribution including the states of NY, MO and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.