Z-1196-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 19, 2014
- Initiation Date
- February 19, 2014
- Termination Date
- April 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 856 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
Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.
Distribution Pattern
US Distribution.
Code Information
Lots: MK761655, MK764022, MK767655, MK526401