Class 2 Device Recall NAMIC Custom Angiographic Kit

• Date Initiated by Firm: August 06, 2008
• Date Posted: November 09, 2008
• Recall Status: Terminated on June 16, 2009
• Recall Number: Z-0287-2009
• Recall Event ID: 49571
• 510(K)Number: K782095
• Product Classification: Cardiopulmonary Bypass Oxygenator - Product Code DTZ
• Product: NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.
• Code Information: UPN/Material #H749601902540, and Lot/Batch # 1280052 (domestic product), Lot/Batch #s and 1275834, 1276658, and 1278843 (foreign)
• Recalling Firm/ Manufacturer: Navilyst Medical; 10 Glens Falls Tech Park; Glens Falls NY 12801
• For Additional Information Contact: Mr. David Greer; 518-742-4519
• Manufacturer Reason for Recall: Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.
• FDA Determined Cause: Process design
• Action: On 8/12/08, Navilyst Medical sent a fax and phoned the sole domestic hospital account that had received the affected units. Navilyst Medical instructed the consignee to immediately locate, segregate, and quarantine the units. The hospital consignee confirmed that all units were still in their control and that they will maintain them in quarantine awaiting return to Navilyst Medical. The sole international account, Boston Scientific in Ireland was notified of the problem on 8/06/08. This was followed up with an Urgent Medical Device Recall Letter and Verification Form sent via FedEx on 8/20/08.
• Quantity in Commerce: Domestic - 20 units; Foreign - 16,200 bulk units
• Distribution: Worldwide Distribution --- USA including state of MO and country of Ireland.
• 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 = DTZ