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U.S. Department of Health and Human Services

Class 2 Device Recall FalopeRing Dilator

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  Class 2 Device Recall FalopeRing Dilator see related information
Date Initiated by Firm July 08, 2014
Date Posted August 19, 2014
Recall Status1 Terminated 3 on May 07, 2015
Recall Number Z-2269-2014
Recall Event ID 68768
PMA Number P870076 
Product Classification Device, occlusion, tubal, contraceptive - Product Code KNH
Product Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.
Code Information catalog No.: 000878-4, not lot controlled.
Recalling Firm/
Manufacturer		 Gyrus Medical, Inc
6655 Wedgwood Rd N Ste 160
Osseo MN 55311-3613
For Additional Information Contact Laura Storms
484-896-5688
Manufacturer Reason
for Recall		 Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.
FDA Determined
Cause 2		 Packaging process control
Action Olympus sent a "Medical Device Recall" letter dated July 7, 2014 to affected customers. The letter was addressed to Surgery Department & Risk Management Department. The letter described the product being recalled, problem and actions to be take. Consignees were advised to immediately cease further use of any affected product and to remove and discard it. Customers were to fax the completed questionnaire to 484-896-7128. For questions contact Laura Storms at 484-896-5688 or at laura.storms@olympus.com
Quantity in Commerce 507 units
Distribution Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, ,MN, MS, NH, HY, OH,OR, PA, TN TX, UT, VA, WA, WI,and WV. and the country of CANADA.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = KNH and Original Applicant = Gyrus ACMI, Inc.
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