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
|