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.
FDA Recall Z-0488-2015 · Posted 2014-12-01
Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHHK
Date Initiated2014-10-27
Date Terminated2015-05-28
Product Quantity30
Reason for Recall
The product has been identified to contain an incorrect curette type.
Firm 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 the recalled product for a full refund or exchange.
If you have any further questions please feel free to call (203) 601.5200.
Root Cause
Packaging process control
Distribution Pattern
US Distribution including the states of NY, MO and NV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.