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U.S. Department of Health and Human Services

Class 2 Device Recall Churchill Medical Systems, Inc. A Vygon Company All sizes of CMSCT6T225 6F Triple Lumen CT PICC

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 Class 2 Recall
Churchill Medical Systems, Inc. A Vygon Company All sizes of CMSCT6T225 6F Triple Lumen CT PICC
see related information
Date Posted March 11, 2013
Recall Status1 Terminated on January 14, 2014
Recall Number Z-0937-2013
Recall Event ID 64458
Premarket Notification
510(K) Number
K081904 
Product Classification Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days - Product Code LJS
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Vygon Corporation
2750 Morris Rd Ste A200
Lansdale, Pennsylvania 19446-6083
Manufacturer 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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Churchill Medical Systems sent a letter to their consignees on December 19, 2012.
Quantity in Commerce 210
Distribution Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = MEDCOMP
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