Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall CooperSurgical

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall CooperSurgicalsee related information
Date Initiated by FirmOctober 27, 2014
Date PostedDecember 01, 2014
Recall Status1 Terminated 3 on May 28, 2015
Recall NumberZ-0488-2015
Recall Event ID 69642
Product Classification Curette, suction, endometrial (and accessories) - Product Code HHK
ProductCooper 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.
Code Information Lot Code: 147234
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Vista Pl
Trumbull CT 06611-3934
For Additional Information Contact
203-601-9818
Manufacturer Reason
for Recall		The product has been identified to contain an incorrect curette type.
FDA Determined
Cause 2		Packaging process control
ActionCooperSurgical 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.
Quantity in Commerce30
DistributionUS Distribution including the states of NY, MO and NV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-