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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 Device Recall Churchill Medical Systems, Inc. A Vygon Company All sizes of CMSCT6T225 6F Triple Lumen CT PICC see related information
Date Initiated by Firm December 17, 2012
Date Posted March 11, 2013
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0937-2013
Recall Event ID 64458
510(K)Number K081904  
Product Classification PICC - 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 PA 19446-6083
For Additional Information Contact
610-539-9300 Ext. 110
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = MEDCOMP
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