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Terminated

ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference Number 23245

FDA Recall Z-0392-2007 · 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 Quantity6090651 - 346 devices, 6090652 - 395 devices, 6090653 - 315 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.

K934624ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVEAdvanced Cardiovascular Systems, Inc. · 1994-04-13

Official Source

View FDA Recall →

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

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