FDA-Device2012-11-28Class II
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Gyrus Acmi, Incorporated
Hazard
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Sold states
Worldwide distribution: USA state of Kansas and country of Korea.
Affected count
10 boxes/60 units
Manufactured in
136 Turnpike Road, N/A, Southborough, MA, United States
Products
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2013Don't want to check this manually?
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