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Terminated

Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA and Boston Scientific Corp., Glens Falls, NY.

FDA Recall Z-0343-06 · Posted 2006-01-06

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-10-28
Date Terminated2007-02-15
Product Quantity50 units

Reason for Recall

Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.

Firm Action

Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.

Root Cause

Other

Distribution Pattern

DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991897CATHETER INNOVATIONS IMPLANTABLE PORTCatheter Innovations, Inc. · 1999-10-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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