FDAFDA · Food and drugs·Recall number Z-0419-2015
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
Published December 3, 2014 · Recall initiated: October 21, 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
All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gyrus Acmi, Incorporated
- Distributor
- Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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