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U.S. Department of Health and Human Services

Class 2 Device Recall Churchill Medical Systems, Inc. a Vygon Company REF CMSCT6T225, 6F Triple Lumen CT PICC with M.S.T.

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  Class 2 Device Recall Churchill Medical Systems, Inc. a Vygon Company REF CMSCT6T225, 6F Triple Lumen CT PICC with M.S.T. see related information
Date Initiated by Firm December 13, 2012
Date Posted February 28, 2013
Recall Status1 Terminated 3 on July 31, 2013
Recall Number Z-0898-2013
Recall Event ID 64235
510(K)Number K081904  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components

Product Usage: Power injectable infusion PICC insertion kits
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/
Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact
Manufacturer Reason
for Recall
The affected 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
Nonconforming Material/Component
Action Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201
Quantity in Commerce 785
Distribution USA Nationwide Distribution including the state of PA.
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