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-1196-2014
Product summary
- Event
- Event 67578
- Status
- Terminated
- Classification
- Class II
- Quantity
- 856 units
- Official record key
device-enforcement:Z-1196-2014
Official wording
Reason: 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.
Code information: Lots: MK761655, MK764022, MK767655, MK526401
Distribution pattern: US Distribution.
Derived failure modes
-
Labeling or packaging
defective seal
-
Sterility assurance
breach of the package's sterile barrier