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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

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

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 Letter
Distribution Pattern Worldwide distribution: USA state of Kansas and country of Korea.