Date Initiated by Firm | April 19, 2011 |
Date Posted | June 11, 2011 |
Recall Status1 |
Terminated 3 on June 18, 2012 |
Recall Number | Z-2389-2011 |
Recall Event ID |
58794 |
Product Classification |
Central Line Dressing Kit - Product Code LKB
|
Product | Churchill Medical Systems
AMS-8316CP-1 (Central Line Dressing Kit).
The device intended use is a central line dressing kit. |
Code Information |
Lot Numbers: 10I60, 10K42 and 10F87. |
Recalling Firm/ Manufacturer |
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 | 4,000 units |
Distribution | United States (FL, MA, MD, and VA). |
Total Product Life Cycle | TPLC Device Report |
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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.
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