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Gyrus Acmi, Incorporated recalls PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy
Recalled November 28, 2012 · FDA recall Z-0411-2013 · Gyrus Acmi, Incorporated
Hazard
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. · FDA Class II
Units
10 boxes/60 units
Sold at
Worldwide distribution: USA state of Kansas and country of Korea.
Description
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Product
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Manufacturer(s)
Gyrus Acmi, Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →