Class 2 Device Recall Atrium HydraGlide Silicone Chest Tube Catheter, 32 Fr

• Date Initiated by Firm: August 10, 2010
• Date Posted: October 07, 2010
• Recall Status: Terminated on April 22, 2016
• Recall Number: Z-0020-2011
• Recall Event ID: 56536
• Product Classification: Catheter, ventricular, general; plastic surgery - Product Code GBS
• Product: HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
• Code Information: Lot 10636876
• Recalling Firm/ Manufacturer: Atrium Medical Corporation; 5 Wentworth Dr; Hudson NH 03051
• For Additional Information Contact: Joseph DePaolo; 603-880-1433
• Manufacturer Reason for Recall: Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.
• FDA Determined Cause: Packaging process control
• Action: Atrium Medical isued Product Recall Notice letters dated August 10, 2010 to customers, identifying the affected product and actions to be taken by customers. Customers were instructed to remove the affected products from inventory and return them to Atrium, and complete and fax a recall notice acknowledgement to Atriuim at 603-821-1420. Customers can contact Atrium at 800 528-7486, x5350 (Joe DePaolo) or x5351 (Karen Hall) for further information.
• Quantity in Commerce: 1 case, 10/case
• Distribution: Nationwide Distribution: USA, including the states of AK, CT, OH, and UT.
• 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.