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Gyrus Acmi, Incorporated recalls GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 1
Recalled June 12, 2013 · FDA recall Z-1439-2013 · Gyrus Acmi, Incorporated
Hazard
lack of sterility assurance · FDA Class II
Units
100 boxes of 6 units
Sold at
Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
Description
lack of sterility assurance
Product
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.
Manufacturer(s)
Gyrus Acmi, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →