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Terminated

Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.

FDA Recall Z-0677-06 · Posted 2006-03-25

Recalling FirmSt. Jude Medical / Daig Division
Recall StatusTerminated
Product CodeMGB
Date Initiated2005-08-22
Date Terminated2006-07-22
Product Quantity4160

Reason for Recall

Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.

Firm Action

Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.

Root Cause

Other

Distribution Pattern

International Only-Belgium, China, Guadalajara, New Zealand and Thailand.

Official Source

View FDA Recall →

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

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