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.

This recall has been terminated (originally issued November 9, 2008).

Company: Navilyst Medical
Recall Initiated: August 6, 2008
Posted: November 9, 2008
Terminated: June 16, 2009
Recall Number: Z-0287-2009
Quantity: Domestic - 20 units; Foreign - 16,200 bulk units
Firm Location: Tech Park Glens Falls, NY
Official Source: View on FDA website ↗

Reason for Recall

Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.

Distribution

Worldwide Distribution --- USA including state of MO and country of Ireland.

Lot / Code Info

UPN/Material #H749601902540, and Lot/Batch # 1280052 (domestic product), Lot/Batch #s and 1275834, 1276658, and 1278843 (foreign)

Root Cause

Process design

Action Taken

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.