FDAFDA · Food and drugs·Recall number Z-0488-2015
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.
Published December 10, 2014 · Recall initiated: October 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product has been identified to contain an incorrect curette type.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperSurgical, Inc.
- Distributor
- US Distribution including the states of NY, MO and NV.
- Lot
- Lot Code: 147234
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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