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U.S. Department of Health and Human Services

Class 2 Device Recall NAMIC Custom Angiographic Kit

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  Class 2 Device Recall NAMIC Custom Angiographic Kit see related information
Date Initiated by Firm August 06, 2008
Date Posted November 09, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = NAMIC
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