Z-0419-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2014
- Initiation Date
- October 21, 2014
- Termination Date
- March 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74,792 units
Product Description
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).
Reason for Recall
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.
Distribution Pattern
Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
Code Information
All lots