Class 2 Device Recall Atrium

• Date Initiated by Firm: May 12, 2008
• Date Posted: August 14, 2008
• Recall Status: Terminated on August 20, 2009
• Recall Number: Z-1834-2008
• Recall Event ID: 48124
• 510(K)Number: K912645
• Product Classification: Thoracic Catheter - Product Code GBS
• Product: HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case
• Code Information: Lot #s 10289970, 10311123, 10311257, 10327131
• Recalling Firm/ Manufacturer: Atrium Medical Corporation; 5 Wentworth Dr; Hudson NH 03051-4929
• For Additional Information Contact: Karen Hall; 603-880-1433
• Manufacturer Reason for Recall: Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
• FDA Determined Cause: Nonconforming Material/Component
• Action: Atrium Medical issued a press release on 5/12/2008 and notified consignees by facsimile on 5/12/2008. Customers were instructed to contact the firm for a return goods authorization and to notify the firm upon receipt of the recall notice.
• Quantity in Commerce: 230 cases (10 individual/case)
• Distribution: Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
• 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 = GBS