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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/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information Contact
215-256-4201
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
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