Recall Z-0419-2015— Gyrus Acmi, Incorporated
Class II · Terminated
Class II FDA medical device recall by Gyrus Acmi, Incorporated, initiated 2014-10-21, terminated 2017-03-03. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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..
- Recalling firm
- Gyrus Acmi, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-21
- Terminated
- 2017-03-03
- Firm location
- Southborough, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.