Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. |
|---|---|
| Recall Number | Z-0937-2013 |
| Classification | Class II |
| Code Info | Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015. |
| Product Distributed Qty | 210 |
| Reason For Recall | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. |
Event Detail
| Event Id | 64458 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Vygon Corporation |
| City | Montgomeryville |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-17 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania |
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