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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63629
Product Type Devices
Status Ongoing
Recalling Firm Gyrus Acmi, Incorporated
City Southborough
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-17
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA state of Kansas and country of Korea.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube JC470075 Class II One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. 10 boxes/60 units Z-0411-2013