Reported Nov 28, 2012 · Terminated
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
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?
- PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
- Lot codes and dates
- JC470075
- Amount recalled
- 10 boxes/60 units
Where it was sold
Why it was recalled
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
This product could cause temporary or reversible health problems — stop using it.
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