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U.S. Department of Health and Human Services

Class 2 Device Recall Churchill Medical

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  Class 2 Device Recall Churchill Medical see related information
Date Initiated by Firm July 15, 2011
Date Posted August 22, 2011
Recall Status1 Terminated 3 on March 27, 2013
Recall Number Z-3049-2011
Recall Event ID 59466
Product Classification kit, i.v. start - Product Code LRS
Product Churchill Medical Latex-Free IV Start Kit
Product Code: AMS-623ATLF

The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label

AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy
Code Information Lot Numbers: 609134, 610166, 611100, 612074, 701180, 703021, 704088 706150, 707106, 708503, 709052, 710051, 711074, 711176 801504, 802064, 803116, 805120, 810040, 810150, 812020 902044, 903117, 906039, 907156, 908040, 910558, 912038 1007141
Recalling Firm/
Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Outer Kit labeled expiration date longer than the expiration of the shortest expired product
FDA Determined
Cause 2
Employee error
Action Churchhill Medical Systems, Inc A Vygon Company issued an URGENT MEDICAL DEVICE RECALL letter was via overnight courier mail on July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The product was requested to be returned. Distributors were provided with instructions to communicate the recall to customers who received the affected product by providing a copy of the notification and a copy of the Recall Acknowledgement and Inventory Return Form. The form should be completed in its entirety, signed and returned to the Distributor. Contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email to customerservice @vygonus.com
Quantity in Commerce 130,750 units
Distribution Nationwide Distribution
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.