FDAFDA · Food and drugs·Recall number Z-1196-2014
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).
Published March 19, 2014 · Recall initiated: February 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gyrus Medical, Inc
- Distributor
- US Distribution.
- Lot
- Lots: MK761655, MK764022, MK767655, MK526401
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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