FDA-Device2014-12-10Class III

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

CooperSurgical, Inc.
Hazard

The product has been identified to contain an incorrect curette type.

Sold states
US Distribution including the states of NY, MO and NV.
Affected count
30
Manufactured in
75 Vista Pl, N/A, Trumbull, CT, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2015

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