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U.S. Department of Health and Human Services

Class 1 Device Recall Churchill Medical Systems

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  Class 1 Device Recall Churchill Medical Systems see related information
Date Initiated by Firm April 19, 2011
Date Posted June 11, 2011
Recall Status1 Terminated 3 on June 18, 2012
Recall Number Z-2391-2011
Recall Event ID 58794
Product Classification Dressing Change Kit - Product Code LKB
Product Churchill Medical Systems
AMS-9189CP-1 (Dressing Change Kit) -Medium Glove.
Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove.

The devices intended use is a Dressing Change Kit.

Code Information AMS-9189CP-1, Lot Numbers: 1006150, 1006149 and 1008143. AMS-9189CP, Lot Number: 1003527.  
Recalling Firm/
Vygon Corporation
103 A Park Drive
Montgomeryville PA 18936-9613
For Additional Information Contact
610-539-9300 Ext. 110
Manufacturer Reason
for Recall
Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination.
FDA Determined
Cause 2
Nonconforming Material/Component
Action A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
Quantity in Commerce AM-9189CP-1 =4,800 units and AM-9189CP= 2,000
Distribution United States (FL, MA, MD, and VA).
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.