Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component o

FDA device recall Z-2269-2014 · posted 2014-08-19 · Terminated

Recall details

Recalling firm

Gyrus Medical, Inc

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.

Action taken

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

Root cause

Packaging process control

Status

Terminated

Product code

KNH

Quantity affected

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.

Date initiated

2014-07-08

Date posted

2014-08-19

Date terminated

2015-05-07

Location

Osseo, MN