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.
FDA Recall Z-0937-2013 · Posted 2013-03-11
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Recalling FirmVygon Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2012-12-17
Date Terminated2014-01-14
Product Quantity210
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.
Firm Action
Churchill Medical Systems sent a letter to their consignees on December 19, 2012.
Root Cause
Component change control
Distribution Pattern
Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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