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. |
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