FDAFDA · Food and drugs·Recall number Z-1439-2013
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
Published June 12, 2013 · Recall initiated: May 24, 2013
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
lack of sterility assurance
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gyrus Acmi, Incorporated
- Distributor
- Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
- Lot
- JC477666
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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