ClearanceBrief
Recall Z-2269-2014 ยท KNH Laparoscopic Contraceptive Tubal Occlusion Device

Gyrus Medical, Inc

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 segmen

DateAug 19, 2014 (initiated Jul 8, 2014)
StatusTerminated
ReasonFalope-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.
Root causePackaging process control
ActionOlympus 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
Quantity507 units
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.