Device product
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).
Z-0419-2015
Product summary
- Event
- Event 69584
- Status
- Terminated
- Classification
- Class II
- Quantity
- 74,792 units
- Official record key
device-enforcement:Z-0419-2015
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
Derived failure modes
-
Foreign material or chemical contamination
contamination that might lead
-
Microbial contamination
bacterial contamination