Reported Jun 12, 2013 · Terminated
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC.,…
Gyrus Acmi, Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gyrus Acmi, Incorporated · 136 Turnpike Road · Southborough, MA · 01772-2118
Is this the product you have?
- 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.
- Lot codes and dates
- JC477666
- Amount recalled
- 100 boxes of 6 units
Where it was sold
- Nationwide
Why it was recalled
lack of sterility assurance
This product could cause temporary or reversible health problems — stop using it.
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