FDAFDA · Food and drugs·Recall number Z-2269-2014
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.
Published August 27, 2014 · Recall initiated: July 8, 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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gyrus Medical, Inc
- Distributor
- 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.
- Lot
- catalog No.: 000878-4, not lot controlled.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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