Gyrus Acmi, Incorporated recalls Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan).

Recalled December 3, 2014 · FDA recall Z-0419-2015 · Gyrus Acmi, Incorporated

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. · FDA Class II

Units

74,792 units

Sold at

Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe

Description

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.

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).

Manufacturer(s)

Gyrus Acmi, Incorporated

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →