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Terminated

ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244

FDA Recall Z-0391-2007 · Posted 2007-02-01

Recalling FirmAbbott Vascular-Cardiac Therapies dba Guidant Corporation
Recall StatusTerminated
Product CodeDTL
Date Initiated2006-12-05
Date Terminated2012-07-24
Product Quantity137 devices

Reason for Recall

Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch

Firm Action

On December 5, 2006, the firm began notifying all affected customers, affiliates and distributors of the recall via letter. The letter advises that the firm has voluntarily recalled specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) due to a potentially incomplete seal in the pouch. The letter advises Abbott Vascular will be replacing all returned product and that appropriate corrective actions will be implemented.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861847ACS ROTATING HEMO VALVE - DUAL ACCESS TYPEAdvanced Cardiovascular Systems, Inc. · 1986-06-16K854261ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVESAdvanced Cardiovascular Systems, Inc. · 1985-12-04

Official Source

View FDA Recall →

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

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